<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04423302</url>
  </required_header>
  <id_info>
    <org_study_id>PEC16075</org_study_id>
    <secondary_id>2020-A00604-35</secondary_id>
    <nct_id>NCT04423302</nct_id>
  </id_info>
  <brief_title>Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)</brief_title>
  <acronym>REVERSE-IT</acronym>
  <official_title>Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valbiotis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biofortis Mérieux NutriSciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Valbiotis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts,&#xD;
      consumed at the daily regimen of three times per day on glucose and lipid homeostasis in&#xD;
      dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior&#xD;
      to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of&#xD;
      consumption.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>2 blinded arms (Active 3 intakes per day and Placebo 3 intakes per day) and 1 open arm (Active 2 intakes per day)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting plasma glucose concentration at V3 with a 3 times a day regimen</measure>
    <time_frame>V3 (24 weeks of intervention)</time_frame>
    <description>Fasting plasma glucose concentration in mg/dL, TOTUM-63 3/day vs placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting plasma glucose concentration</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Fasting plasma glucose concentration (in mg/dL), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the HbA1c</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>HbA1c (in %), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the glycemia at 120 minutes following the 75g glucose intake</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention), V3 (24 weeks of intervention) and V4 (12 weeks and the end of intervention)</time_frame>
    <description>Glycemia (in mg/dL) at 120 minutes following the 75g glucose intake, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo (Only for a subgroup of 201 subjects)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting insulinemia</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Fasting insulinemia (in mU/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the HOMA-IR (HOmeostasis Model Assessment of Insulin Resistance) index</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>HOMA-IR index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the HOMA-β (Homeostasis Model Assessment of Beta cells) index</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>HOMA-β index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the QUICKY (QUantitative Insulin sensitivity ChecK Index) index</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>QUICKY index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting blood concentrations of triglycerides</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Triglycerides (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting blood concentrations of total cholesterol</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Total cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting blood concentrations of HDL cholesterol</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>HDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting blood concentrations of non-HDL cholesterol</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>non-HDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting blood concentrations of LDL cholesterol</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>LDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting blood concentrations of free fatty acids</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Free fatty acids (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of atherogenic index</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Atherogenic index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of atherogenic coefficient</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Atherogenic coefficient, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Cardiac risk ratio 1</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Cardiac risk ratio 1, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of cardiac risk ratio 2</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Cardiac risk ratio 2, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the fasting blood concentrations of hsCRP</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>hsCRP (in mg/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the body weight</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Body weight (in kg), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the waist circumference</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Waist circumference (in cm), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the hip circumference</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Hip circumference (in cm), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the waist to hip ratio</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Waist to hip ratio, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the body composition assessed by impedancemeter</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Fat mass (in % and kg), lean mass (in % and kg), total body water (in % and kg), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay of occurence of pharmacological treatment requirement for type 2 diabetes from V1</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Delay between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his diabetes, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects having an improvement or a deterioration of their glycemic status from V1</measure>
    <time_frame>V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)</time_frame>
    <description>Glycemic status will be defined at each visit by the FPG value, 3 different categories Type 2 diabetes/prediabetic/normal. Proportion of subjects changing from category during the study will be assessed during the study (improvement of the glycemic status or deterioration), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Prediabetic State</condition>
  <condition>Diabetes type2</condition>
  <condition>Dysglycemia</condition>
  <arm_group>
    <arm_group_label>TOTUM-63 3 intakes per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental active diet supplement TOTUM-63 taken 3 times per day (blinded arm)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 3 intakes per day</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo comparator taken 3 times per day (blinded arm)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TOTUM-63 2 intakes per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental active diet supplement TOTUM-63 taken 2 times per day (open arm)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>TOTUM-63 3 intakes per day</intervention_name>
    <description>5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)</description>
    <arm_group_label>TOTUM-63 3 intakes per day</arm_group_label>
    <other_name>Active product 3 intakes per day</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo 3 intakes per day</intervention_name>
    <description>Placebo. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)</description>
    <arm_group_label>Placebo 3 intakes per day</arm_group_label>
    <other_name>Comparator product 3 intakes per day</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>TOTUM-63 2 intakes per day</intervention_name>
    <description>5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes (4 in the morning and 4 at dinner)</description>
    <arm_group_label>TOTUM-63 2 intakes per day</arm_group_label>
    <other_name>Active product 2 intakes per day</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  I1. From 18 to 70 years (including ranges);&#xD;
&#xD;
          -  I2. Dysglycemic, prediabetic or newly diagnosed type 2 diabetes, subject without any&#xD;
             clinical symptoms of diabetes (e.g. polyuria, polydipsia, blurred vision…) and not&#xD;
             requiring immediate anti-diabetic treatment;&#xD;
&#xD;
          -  I3. Body mass index (BMI) between 25 and 40 kg/m² (including ranges);&#xD;
&#xD;
          -  I4. Waist circumference &gt; 102 cm for men and &gt; 88 cm for women (-2% margin allowed,&#xD;
             respectively ≥ 100 cm and ≥ 86.5 cm);&#xD;
&#xD;
          -  I5. Weight stable within ± 5% in the last three months;&#xD;
&#xD;
          -  I6. No significant change in food habits or in physical activity in the 3 months&#xD;
             before the randomization and agreeing to follow hygiene and dietary (HD)&#xD;
             recommendations given during the study;&#xD;
&#xD;
          -  I7. For women: Non-menopausal with the same reliable contraception since at least&#xD;
             three months before the beginning of the study and agreeing to keep it during the&#xD;
             entire duration of the study (hormonal contraception, intra uterine device or surgical&#xD;
             intervention) or menopausal with or without hormone replacement therapy (estrogenic&#xD;
             replacement therapy begun from less than 3 months excluded);&#xD;
&#xD;
          -  I8. Good general and mental health according to the opinion of the investigator: no&#xD;
             clinically significant and relevant abnormalities of medical history or physical&#xD;
             examination;&#xD;
&#xD;
          -  I9. Able and willing to participate to the study by complying with the protocol&#xD;
             procedures as evidenced by his dated and signed informed consent form;&#xD;
&#xD;
          -  I10. Affiliated with a social security scheme;&#xD;
&#xD;
          -  I11. Agreeing to be registered on the volunteers in biomedical research (applicable&#xD;
             only for French centers).&#xD;
&#xD;
        At V0 biological analysis, the subjects will be eligible to the study on the following&#xD;
        criteria:&#xD;
&#xD;
          -  I12. Fasting plasma glucose concentration ≥ 110 mg/dL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  E1. Suffering from a metabolic disorder such as treated diabetes, uncontrolled&#xD;
             thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug&#xD;
             intervention according to the professional recommendations;&#xD;
&#xD;
          -  E2. Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥&#xD;
             160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);&#xD;
&#xD;
          -  E3. With a history of retinopathy, ischemic cardiovascular event, having undergone&#xD;
             recent surgical procedure in the past 6 months or in the 9 months to come;&#xD;
&#xD;
          -  E4. Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic&#xD;
             or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or&#xD;
             other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be&#xD;
             inconsistent with the conduct of the study by the investigator (e.g. celiac disease);&#xD;
&#xD;
          -  E5. Under antidiabetic drug (e.g. biguanides, sulfonylureas, glinides, gliptins,&#xD;
             glitazones, gliflozins, α-glucosidase inhibitors, incretins and insulin);&#xD;
&#xD;
          -  E6. Under lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid&#xD;
             sequestrants, niacin, etc.) since less than 3 months or modification of the treatment&#xD;
             dose since less than 3 months before the randomization. Subject with a stable&#xD;
             lipid-lowering treatment since at least three months can be included in the study;&#xD;
&#xD;
          -  E7. Under medication which could affect glucose and/or lipid homeostasis parameters or&#xD;
             stopped less than 3 months before randomization (e.g. beta 2 agonists like salbutamol,&#xD;
             Angiotensin Converting Enzyme (ACE) inhibitors, beta blockers, thiazide diuretics,&#xD;
             Selective Serotonin Reuptake Inhibitors (SSRIs), Mono-Amine Oxidase Inhibitors&#xD;
             (MAOIs), neuroleptics, long-term corticosteroid systemic drugs, systemic antibodies,&#xD;
             androgens, phenytoin, interferons, immunosuppressants, antivirals and antiretrovirals,&#xD;
             etc.):&#xD;
&#xD;
               -  Beta 2 agonists like salbutamol, ACE inhibitors, beta blockers, thiazide&#xD;
                  diuretics, SSRIs, MAOIs are tolerated only if stable since more than 3 months&#xD;
                  before the randomization and maintained during the whole study;&#xD;
&#xD;
               -  The others drugs (neuroleptics, long-term corticosteroid systemic drugs, systemic&#xD;
                  antibodies, androgens, phenytoin, interferons, immunosuppressants, antivirals and&#xD;
                  antiretrovirals, etc.) are not allowed during the study;&#xD;
&#xD;
          -  E8. Regular intake of dietary supplements or &quot;health foods&quot;, or products rich in plant&#xD;
             stanol or sterol (like Pro-Activ® or Danacol® products), rich in long chain omega-3&#xD;
             fatty acids (especially soft gels containing fish oils), or in other substances&#xD;
             intended to reduce glycemia (e.g. beta-glucans, konjac, olive leaf extract, berberine,&#xD;
             cinnamon, etc.) or stopped less than 3 months before the randomization;&#xD;
&#xD;
          -  E9. Under treatment or dietary supplement which could significantly affect&#xD;
             parameter(s) followed during the study according to the investigator or stopped in a&#xD;
             too short period before the randomization (for example consumed in the month before&#xD;
             the randomization);&#xD;
&#xD;
          -  E10. With a known or suspected food allergy or intolerance or hypersensitivity to any&#xD;
             of the study products' ingredient;&#xD;
&#xD;
          -  E11. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2&#xD;
             standard drinks daily for women or not agreeing to keep his alcohol consumption habits&#xD;
             unchanged throughout the study;&#xD;
&#xD;
          -  E12. With extreme and/or unbalanced eating habits (e.g. vegetarian, vegan, skipping&#xD;
             meals regularly);&#xD;
&#xD;
          -  E13. With a personal history of anorexia nervosa, bulimia or significant eating&#xD;
             disorders according to the investigator;&#xD;
&#xD;
          -  E14. Smoking more than 20 cigarettes daily or not agreeing to keep his smoking habits&#xD;
             unchanged throughout the study. The subject should be able not to smoke during the&#xD;
             visits (maximum 4 hours);&#xD;
&#xD;
          -  E15. Having a lifestyle deemed incompatible with the study according to the&#xD;
             investigator including high level of physical activity (defined as more than 10 hours&#xD;
             of intense physical activity a week, walking excluded);&#xD;
&#xD;
          -  E16. Pregnant (as evidenced by a positive test for β-HCG (Human Chorionic&#xD;
             Gonadotropin), i.e. &gt; 5 mUI/mL, realized at V0) or lactating women or intending to&#xD;
             become pregnant within 9 months ahead;&#xD;
&#xD;
          -  E17. Who made a blood donation in the 3 months before the randomization or intending&#xD;
             to make it within 9 months ahead;&#xD;
&#xD;
          -  E18. Taking part in another clinical trial or being in the exclusion period of a&#xD;
             previous clinical trial;&#xD;
&#xD;
          -  E19. Having received, during the last 12 months, indemnities for clinical trial higher&#xD;
             or equal to 4500 Euros (applicable only for French centers);&#xD;
&#xD;
          -  E20. Under legal protection (guardianship, wardship) or deprived from his rights&#xD;
             following administrative or judicial decision;&#xD;
&#xD;
          -  E21. Presenting a psychological or linguistic incapability to sign the informed&#xD;
             consent;&#xD;
&#xD;
          -  E22. Impossible to contact in case of emergency;&#xD;
&#xD;
          -  E23. Any condition assessed by the investigator which could endanger patient safety or&#xD;
             the conduct of the study (e.g. device related contraindication for impedancemetry&#xD;
             and/or DEXA (Dual-Energy X-ray Absorptiometry) such as pacemaker or electronic&#xD;
             implant);&#xD;
&#xD;
        At V0 biological analysis, the subjects will be considered as non-eligible to the study on&#xD;
        the following criteria:&#xD;
&#xD;
          -  E24. Fasting glucose plasma concentration &gt; 220 mg/dL;&#xD;
&#xD;
          -  E25. Fasting blood triglycerides &gt; 2.2 g/L;&#xD;
&#xD;
          -  E26. TSH (Thyroid Stimulating Hormone) outside the laboratory normal values;&#xD;
&#xD;
          -  E27. Fasting blood LDL (Low Density Lipoprotein) cholesterol &gt; 1.9 g/L or non HDLc&#xD;
             (High Density Lipoprotein cholesterol) &gt; 2.2 g/L or any condition requiring a&#xD;
             therapeutic dose adjustment during the trial according to the professional&#xD;
             recommendations;&#xD;
&#xD;
          -  E28. Blood AST (ASpartate amino Transferase), ALT (ALanine amino Transferase) or GGT&#xD;
             (Gamma Glutamyl Transpeptidase) &gt; 3 x ULN (Upper Limit of Normal);&#xD;
&#xD;
          -  E29. Blood creatinine concentration &gt; 125 μmol/L;&#xD;
&#xD;
          -  E30. eGFR estimated Glomerular Filtration Rate, calculated by CKD-EPI (Chronic Kidney&#xD;
             Disease-EPIdemiology collaboration) formula) &lt; 60 mL/min/1.73m²;&#xD;
&#xD;
          -  E31. Complete blood count (CBC) with hemoglobin &lt; 11 g/dL or leucocytes &lt; 3000 /mm3 or&#xD;
             leucocytes &gt; 16000 /mm3 or clinically significant abnormality according to the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle METREAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biofortis Mérieux NutriSciences</affiliation>
  </overall_official>
  <location>
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    <facility>
      <name>MHAT Sveta Karidad, First department of Internal Diseases</name>
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  <location>
    <facility>
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  <location>
    <facility>
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        <city>Plovdiv</city>
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  <location>
    <facility>
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        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
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  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for active treatment &quot;Alexandrovska&quot; EAD Clinic of Endocrinology and metabolic diseases</name>
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  <location>
    <facility>
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        <zip>1606</zip>
        <country>Bulgaria</country>
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  <location>
    <facility>
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      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
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  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>CH Arras</name>
      <address>
        <city>Arras</city>
        <zip>62000</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>CIC Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>CEN Nutriment</name>
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        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Eurofins Optimed</name>
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        <city>Gières</city>
        <zip>38610</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Institut Pasteur de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59019</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nice</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Unité d'Investigation Clinique Biofortis Mérieux NutriSciences</name>
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        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Unité de Recherche Clinique en Immunologie Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Biofortis Mérieux NutriSciences</name>
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        <city>Saint-Herblain</city>
        <zip>44800</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Analyze &amp; Realize</name>
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        <zip>13467</zip>
        <country>Germany</country>
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  <location>
    <facility>
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        <city>Dresden</city>
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  <location>
    <facility>
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        <zip>45355</zip>
        <country>Germany</country>
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  </location>
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    <facility>
      <name>Biotesys</name>
      <address>
        <city>Esslingen</city>
        <zip>73728</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
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        <city>Hamburg</city>
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  </location>
  <location>
    <facility>
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        <city>Hannover</city>
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  </location>
  <location>
    <facility>
      <name>Klinische Forschung Karlsruhe</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dr. Med C. Klein/J Minnich</name>
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        <city>Künzing</city>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
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        <city>Sankt Ingbert</city>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Klinische Forschung Schwerin</name>
      <address>
        <city>Schwerin</city>
        <zip>19055</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum für Klinische Ernährung Stuttgart</name>
      <address>
        <city>Stuttgart</city>
        <zip>70599</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Drug Resesarch Center (DRC)</name>
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        <city>Balatonfüred</city>
        <zip>8230</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <name>ClinExpert Medical Center</name>
      <address>
        <city>Budapest</city>
        <zip>1033</zip>
        <country>Hungary</country>
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  </location>
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    <facility>
      <name>Trial Pharma Ltd</name>
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        <city>Békéscsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <name>Agria - Study Ltd</name>
      <address>
        <city>Eger</city>
        <zip>3300</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <name>Trial Pharma Ltd</name>
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        <city>Gyula</city>
        <zip>5703</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <name>Trial Pharma Ltd</name>
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        <city>Győr</city>
        <zip>9000</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Unit (CRU)</name>
      <address>
        <city>Miskolc</city>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Pharma Ltd</name>
      <address>
        <city>Orosháza</city>
        <zip>5900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria &quot;Mater Domini&quot;</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Raffaele</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
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  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico &quot;Paolo Giaccone&quot;</name>
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        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Vitamed</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grupowa Praktyka Lekarska s.c</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Linden</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Monitoring</name>
      <address>
        <city>Bucarest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Municipal Caracal</name>
      <address>
        <city>Caracal</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ames Research Cente</name>
      <address>
        <city>Călăraşi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clintrial Medical Center</name>
      <address>
        <city>Reșca</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Romania</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dysglycemia</keyword>
  <keyword>Prediabetes</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Hyperglycemia</keyword>
  <keyword>Insulinemia</keyword>
  <keyword>Diabetes risk</keyword>
  <keyword>Diet supplement</keyword>
  <keyword>Plant extracts</keyword>
  <keyword>Health condition</keyword>
  <keyword>Hygiene and dietary recommendations</keyword>
  <keyword>Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04423302
org study id: PEC16075
secondary id: 2020-A00604-35
nct id: NCT04423302
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts,
      consumed at the daily regimen of three times per day on glucose and lipid homeostasis in
      dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior
      to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of
      consumption.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: 2 blinded arms (Active 3 intakes per day and Placebo 3 intakes per day) and 1 open arm (Active 2 intakes per day)
measure: Fasting plasma glucose concentration at V3 with a 3 times a day regimen
time frame: V3 (24 weeks of intervention)
description: Fasting plasma glucose concentration in mg/dL, TOTUM-63 3/day vs placebo
measure: Evolution of the fasting plasma glucose concentration
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Fasting plasma glucose concentration (in mg/dL), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the HbA1c
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: HbA1c (in %), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the glycemia at 120 minutes following the 75g glucose intake
time frame: V1 (baseline), V2 (12 weeks of intervention), V3 (24 weeks of intervention) and V4 (12 weeks and the end of intervention)
description: Glycemia (in mg/dL) at 120 minutes following the 75g glucose intake, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo (Only for a subgroup of 201 subjects)
measure: Evolution of the fasting insulinemia
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Fasting insulinemia (in mU/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the HOMA-IR (HOmeostasis Model Assessment of Insulin Resistance) index
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: HOMA-IR index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the HOMA-β (Homeostasis Model Assessment of Beta cells) index
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: HOMA-β index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the QUICKY (QUantitative Insulin sensitivity ChecK Index) index
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: QUICKY index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the fasting blood concentrations of triglycerides
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Triglycerides (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the fasting blood concentrations of total cholesterol
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Total cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the fasting blood concentrations of HDL cholesterol
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: HDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the fasting blood concentrations of non-HDL cholesterol
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: non-HDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the fasting blood concentrations of LDL cholesterol
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: LDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the fasting blood concentrations of free fatty acids
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Free fatty acids (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of atherogenic index
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Atherogenic index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of atherogenic coefficient
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Atherogenic coefficient, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of Cardiac risk ratio 1
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Cardiac risk ratio 1, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of cardiac risk ratio 2
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Cardiac risk ratio 2, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the fasting blood concentrations of hsCRP
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: hsCRP (in mg/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the body weight
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Body weight (in kg), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the waist circumference
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Waist circumference (in cm), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the hip circumference
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Hip circumference (in cm), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the waist to hip ratio
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Waist to hip ratio, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Evolution of the body composition assessed by impedancemeter
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Fat mass (in % and kg), lean mass (in % and kg), total body water (in % and kg), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Delay of occurence of pharmacological treatment requirement for type 2 diabetes from V1
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Delay between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his diabetes, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
measure: Proportion of subjects having an improvement or a deterioration of their glycemic status from V1
time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
description: Glycemic status will be defined at each visit by the FPG value, 3 different categories Type 2 diabetes/prediabetic/normal. Proportion of subjects changing from category during the study will be assessed during the study (improvement of the glycemic status or deterioration), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
arm group label: TOTUM-63 3 intakes per day
arm group type: Experimental
description: Experimental active diet supplement TOTUM-63 taken 3 times per day (blinded arm)
arm group label: Placebo 3 intakes per day
arm group type: Placebo Comparator
description: Placebo comparator taken 3 times per day (blinded arm)
arm group label: TOTUM-63 2 intakes per day
arm group type: Experimental
description: Experimental active diet supplement TOTUM-63 taken 2 times per day (open arm)
intervention type: Dietary Supplement
intervention name: TOTUM-63 3 intakes per day
description: 5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)
arm group label: TOTUM-63 3 intakes per day
other name: Active product 3 intakes per day
intervention type: Dietary Supplement
intervention name: Placebo 3 intakes per day
description: Placebo. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)
arm group label: Placebo 3 intakes per day
other name: Comparator product 3 intakes per day
intervention type: Dietary Supplement
intervention name: TOTUM-63 2 intakes per day
description: 5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes (4 in the morning and 4 at dinner)
arm group label: TOTUM-63 2 intakes per day
other name: Active product 2 intakes per day
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Isabelle METREAU, MD
role: Principal Investigator
affiliation: Biofortis Mérieux NutriSciences
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country: Bulgaria
country: France
country: Germany
country: Hungary
country: Italy
country: Poland
country: Romania
responsible party type: Sponsor
mesh term: Prediabetic State
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No