<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/NCT04488653</url>
  </required_header>
  <id_info>
    <org_study_id>19PMHD</org_study_id>
    <nct_id>NCT04488653</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Les Derives Resiniques et Terpeniques</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KGK Science Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Les Derives Resiniques et Terpeniques</source>
  <oversight_info>
    <has_dmc>No</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>
      The safety and efficacy of Oligopin® will be compared against a placebo to evaluate the&#xD;
      effect on metabolic risk factors in subjects with metabolic syndrome. During the 84-day study&#xD;
      period it is hypothesized that HDL cholesterol will increase and systolic blood pressure will&#xD;
      decrease therefore lowering CVD risk factors after supplementation with Oligopin®.&#xD;
      Additionally, it is hypothesized that Oligopin® supplementation will reduce fasting glucose&#xD;
      levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Metabolic syndrome (MetS) is a combination of risk factors for chronic conditions such as&#xD;
      cardiovascular disease (CVD) and type 2 diabetes (T2D). These risk factors include obesity&#xD;
      (particularly abdominal obesity), high blood pressure, elevated triglycerides, low&#xD;
      high-density lipoprotein (HDL) cholesterol, and elevated fasting blood glucose. MetS reflects&#xD;
      overnutrition and sedentary lifestyles as the prevalence of MetS increases concomitantly with&#xD;
      these lifestyle choices. Most recent estimates suggest that approximately 19.1% of the&#xD;
      Canadian population, 34.2% of the US population, and 24.3% of the European population have&#xD;
      MetS. Significantly, the prevalence of MetS in adults aged 18-39 has increased dramatically&#xD;
      over the last 2 decades.&#xD;
&#xD;
      MetS commonly precedes the development of CVD and is associated with a 2-fold increase in the&#xD;
      risk of CVD mortality. MetS also increases the risk of developing T2D and is suggested to be&#xD;
      extremely prevalent (90-95%) in Caucasian individuals diagnosed with T2D. Indeed, the&#xD;
      presence of even one MetS risk factor early in life increases the chances of developing a&#xD;
      chronic disease later in life. Currently, MetS risk factors are estimated to be present in&#xD;
      4.8-7% of individuals from 18 to 30 years of age. Therefore, preventing the development of or&#xD;
      treating these risk factors earlier in life could reduce the development of chronic disease.&#xD;
&#xD;
      The pathogenic mechanisms of MetS remain to be fully elucidated, however insulin resistance&#xD;
      (IR) appears to play a pivotal role in the initiation and progression of the syndrome.&#xD;
      Abdominal obesity is a well-known contributor to IR. Abdominal fat accumulation increases the&#xD;
      supply of free fatty acids (FFAs) to the liver and indirectly results in an increase in&#xD;
      plasma low-density lipoprotein (LDL) cholesterol and a decrease in HDL cholesterol. IR also&#xD;
      elevates fasting blood glucose levels due to the suppression of hepatic glycogen synthesis&#xD;
      and impairs postprandial glucose control by reducing insulin stimulated glucose uptake by&#xD;
      peripheral tissues.&#xD;
&#xD;
      There is a need for natural interventions that aid in the prevention and treatment of MetS&#xD;
      risk factors as the prevalence of overnutrition and sedentary lifestyles continues to&#xD;
      increase. This study will assess the ability of Oligopin® to improve abdominal obesity,&#xD;
      fasting blood glucose, postprandial glucose and insulin response, and HDL-cholesterol levels&#xD;
      as these outcomes reliably predict an individual's MetS risk. Oligopin® is a French Maritime&#xD;
      Pine Bark Extract (FMPBE) obtained from the pine tree Pinus pinaster. It is rich in low&#xD;
      molecular weight oligomeric procyanidins (OPC) with 20% of OPCs in the form of dimers as&#xD;
      compared to the most studied FMPBE Pycogenol®, which contains only 5% of OPCs as dimers.&#xD;
&#xD;
      Recently, Oligopin® supplementation was shown to reduce CVD risk factors. In a randomized,&#xD;
      double-blind, placebo-controlled clinical trial, Oligopin® consumption increased HDL&#xD;
      cholesterol levels and reduced systolic blood pressure and oxidized LDL (oxLDL) levels in&#xD;
      stage 1 hypertensive individuals. This is significant as low HDL was reported to be the most&#xD;
      prevalent risk factor for the development of MetS in young adults. FMPBE supplementation has&#xD;
      also been shown to reduce fasting glucose levels in individuals with T2D. Interestingly,&#xD;
      FMPBE is a potent inhibitor of α-glucosidase, which catalyses the breakdown of&#xD;
      oligosaccharides in the small intestine to permit glucose resorption. Therefore, it is&#xD;
      possible that Oligopin® may reduce fasting glucose levels and control postprandial&#xD;
      hyperglycemia. This randomized, double-blind, placebo-controlled study will determine the&#xD;
      efficacy of Oligopin® to improve markers of metabolic risk in subjects with MetS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Anticipated">January 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 19, 2021</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting blood sugar level</measure>
    <time_frame>84 days</time_frame>
    <description>Change in fasting blood sugar from baseline to day 84 between Oligopin® and placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting insulin concentration</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in fasting insulin between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose level</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in fasting glucose between Oligopin® and placebo baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of fasting low-density lipoprotein (LDL)</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in fasting LDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting oxidized LDL (oxLDL).</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in fasting oxLDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting high-density lipoprotein (HDL)</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in fasting HDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting total cholesterol</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in fasting total cholesterol between Oligopin® and placebo baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial glucose at 20, 30, 90, or 120 min after meal</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in postprandial glucose between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial insulin at 20, 30, 90, or 120 min after meal</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in postprandial glucose between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in BMI between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in waist circumference between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline, day 42 and day 84</time_frame>
    <description>Change in systolic and diastolic blood pressure between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>84 days</time_frame>
    <description>Change in heart rate between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine aminotransferase (ALT)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in ALT between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate transaminase (AST)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in AST between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total bilirubin</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in total bilirubin between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in creatinine between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium ion</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in sodium ion between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium ion</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in potassium ion between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chloride ion</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in chloride ion between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in eGFR between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White blood cell (WBC) count</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in WBC count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutrophils</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in neutrophil count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphocytes</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in lymphocyte count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocytes</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in monocyte count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eosinophils</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in eosinophil count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basophils</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in basophil count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red blood cell (RBC)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in RBC count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in hemoglobin level between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in hematocrit level between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in platelet count between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean corpuscular volume (MCV)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in MCV level between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean corpuscular hemoglobin (MCH)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in MCH level between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean corpuscular hemoglobin concentration (MCHC)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in MCHC level between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean platelet volume (MPV)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in MPV level between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red cell distribution width (RDW)</measure>
    <time_frame>Pre-baseline and 84 days</time_frame>
    <description>Change in RDW level between Oligopin® and placebo pre-baseline and day 84.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Oligopin®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oligopin® contains French Maritime Pine Bark Extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is a mixture of different inert compounds</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oligopin®</intervention_name>
    <description>French Maritime Pine Bark Extract - 100mg/day</description>
    <arm_group_label>Oligopin®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maltodextrin</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provided voluntary, written, informed consent to participate in the study&#xD;
&#xD;
          -  Males and females between 18 and 55 years of age, inclusive&#xD;
&#xD;
          -  Female participant is not of child-bearing potential, defined as females who have&#xD;
             undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy,&#xD;
             bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for&#xD;
             at least 1 year prior to screening Or,&#xD;
&#xD;
        Females of child-bearing potential must have a negative baseline urine pregnancy test and&#xD;
        agree to use a medically approved method of birth control for the duration of the study.&#xD;
        All hormonal birth control must have been in use for a minimum of three months. Acceptable&#xD;
        methods of birth control include:&#xD;
&#xD;
          -  Hormonal contraceptives including oral contraceptives, hormone birth control patch&#xD;
             (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-&#xD;
&#xD;
          -  Provera, Lunelle), or hormone implant (Norplant System)&#xD;
&#xD;
          -  Double-barrier method&#xD;
&#xD;
          -  Intrauterine devices&#xD;
&#xD;
          -  Non-heterosexual lifestyle or agrees to use contraception if planning on changing to&#xD;
             heterosexual partner(s)&#xD;
&#xD;
          -  Vasectomy of partner at least 6 months prior to screening&#xD;
&#xD;
          -  BMI between 25 to 34.9 kg/m2, inclusive&#xD;
&#xD;
          -  Subjects with three or more of the following markers associated with metabolic&#xD;
             syndrome:&#xD;
&#xD;
          -  Abdominal obesity: waist circumference &gt; 102 cm (40 inches) in men and &gt; 88 cm (35&#xD;
             inches) in women&#xD;
&#xD;
          -  Hypertension: systolic blood pressure &gt; 130 mmHg or diastolic blood pressure &gt; 85 mmHg&#xD;
&#xD;
          -  Elevated fasting glucose &gt; 5.6 mmol/L (&gt; 100 mg/dL) and &lt; 7.0 mmol/L (&lt; 126 mg/dL)&#xD;
             and/or elevated HbA1c (6.0-6.4%)&#xD;
&#xD;
          -  Elevated TG: &gt; 150 mg/dL (1.7 mmol/L)&#xD;
&#xD;
          -  Low HDL-C: &lt; 40 mg/dL (1.03 mmol/L) in men and &lt; 50 mg/dL (1.29 mmol/L) in women&#xD;
&#xD;
          -  Stable weight defined as &lt; 5% change in body weight in six months prior to beginning&#xD;
             of study&#xD;
&#xD;
          -  Agrees to maintain current diet and exercise routine during the study&#xD;
&#xD;
          -  Agrees to comply with all study-related procedures&#xD;
&#xD;
          -  Otherwise healthy as determined by medical history, laboratory results, and physical&#xD;
             exam as assessed by the Qualified Investigator (QI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, breast feeding, or planning to become pregnant during the&#xD;
             trial&#xD;
&#xD;
          -  Blood donation 30 days prior to screening, during the study, or a planned donation&#xD;
             within 30-days of the last study visit&#xD;
&#xD;
          -  Participation in other clinical research trials 30 days prior to screening&#xD;
&#xD;
          -  Individuals who are unable to give informed consent&#xD;
&#xD;
          -  Current or history of any significant diseases of the gastrointestinal tract that may&#xD;
             impact study outcomes as assessed by the QI&#xD;
&#xD;
          -  Unstable metabolic disease or chronic diseases as assessed by the QI&#xD;
&#xD;
          -  Unstable hypertension as assessed by the QI&#xD;
&#xD;
          -  Type I or Type II diabetes&#xD;
&#xD;
          -  Individuals with hypercholesterolemia and/or elevated triglycerides who are receiving&#xD;
             medications to modulate lipid metabolism, as in Sections 6.3.1 and 6.3.2&#xD;
&#xD;
          -  Individuals with an autoimmune disease or who are immune-compromised&#xD;
&#xD;
          -  Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis&#xD;
&#xD;
          -  History of or current diagnosis with kidney and/or liver diseases as assessed by the&#xD;
             QI on a case-by-case basis, with the exception of history of kidney stones symptom&#xD;
             free for 6 months&#xD;
&#xD;
          -  Self-reported current or pre-existing thyroid condition. Treatment on a stable dose of&#xD;
             medication for at least 3 months will be considered by the QI&#xD;
&#xD;
          -  Self-reported medical or neuropsychological condition and/or cognitive impairment&#xD;
             that, in the QI's opinion, could interfere with study participation&#xD;
&#xD;
          -  Self-reported blood/bleeding disorder&#xD;
&#xD;
          -  Serious cardiovascular or respiratory disease as assessed by the QI.&#xD;
&#xD;
          -  Major surgery in the past 3 months or individuals who have planned surgery during the&#xD;
             course of the trial. Participants with minor surgery will be considered on a&#xD;
             case-by-case basis by the QI&#xD;
&#xD;
          -  Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or&#xD;
             radiation with a follow up that is negative. Volunteers with cancer in full remission&#xD;
             for more than five years after diagnosis are acceptable&#xD;
&#xD;
          -  Allergy, sensitivity, or intolerance to the investigational product's active or&#xD;
             inactive ingredients, or the ingredients in the test meal&#xD;
&#xD;
          -  Current use of prescribed medications listed in Section 6.3.1&#xD;
&#xD;
          -  Current use of over-the-counter medications, supplements, foods and/or drinks listed&#xD;
             in Section 6.3.2&#xD;
&#xD;
          -  Medical use of cannabinoid products&#xD;
&#xD;
          -  Chronic recreational use of cannabinoid products (&gt;2 times/week). Occasional use will&#xD;
             be assessed by the QI on a case-by-case basis&#xD;
&#xD;
          -  Use of tobacco or nicotine-containing products within 60 days of screening&#xD;
&#xD;
          -  Alcohol or drug abuse within the last 12 months&#xD;
&#xD;
          -  High alcohol intake (average of &gt;2 standard drinks per day&#xD;
&#xD;
          -  Clinically significant abnormal laboratory results at screening as assessed by the QI&#xD;
&#xD;
          -  Any other condition, that, in the opinion of the QI, may adversely affect the&#xD;
             participant's ability to complete the study or its measures or pose significant risk&#xD;
             to the participant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Crowley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KGK Science Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KGK Science Inc.</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04488653
org study id: 19PMHD
nct id: NCT04488653
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The safety and efficacy of Oligopin® will be compared against a placebo to evaluate the
      effect on metabolic risk factors in subjects with metabolic syndrome. During the 84-day study
      period it is hypothesized that HDL cholesterol will increase and systolic blood pressure will
      decrease therefore lowering CVD risk factors after supplementation with Oligopin®.
      Additionally, it is hypothesized that Oligopin® supplementation will reduce fasting glucose
      levels.
Metabolic syndrome (MetS) is a combination of risk factors for chronic conditions such as
      cardiovascular disease (CVD) and type 2 diabetes (T2D). These risk factors include obesity
      (particularly abdominal obesity), high blood pressure, elevated triglycerides, low
      high-density lipoprotein (HDL) cholesterol, and elevated fasting blood glucose. MetS reflects
      overnutrition and sedentary lifestyles as the prevalence of MetS increases concomitantly with
      these lifestyle choices. Most recent estimates suggest that approximately 19.1% of the
      Canadian population, 34.2% of the US population, and 24.3% of the European population have
      MetS. Significantly, the prevalence of MetS in adults aged 18-39 has increased dramatically
      over the last 2 decades.

      MetS commonly precedes the development of CVD and is associated with a 2-fold increase in the
      risk of CVD mortality. MetS also increases the risk of developing T2D and is suggested to be
      extremely prevalent (90-95%) in Caucasian individuals diagnosed with T2D. Indeed, the
      presence of even one MetS risk factor early in life increases the chances of developing a
      chronic disease later in life. Currently, MetS risk factors are estimated to be present in
      4.8-7% of individuals from 18 to 30 years of age. Therefore, preventing the development of or
      treating these risk factors earlier in life could reduce the development of chronic disease.

      The pathogenic mechanisms of MetS remain to be fully elucidated, however insulin resistance
      (IR) appears to play a pivotal role in the initiation and progression of the syndrome.
      Abdominal obesity is a well-known contributor to IR. Abdominal fat accumulation increases the
      supply of free fatty acids (FFAs) to the liver and indirectly results in an increase in
      plasma low-density lipoprotein (LDL) cholesterol and a decrease in HDL cholesterol. IR also
      elevates fasting blood glucose levels due to the suppression of hepatic glycogen synthesis
      and impairs postprandial glucose control by reducing insulin stimulated glucose uptake by
      peripheral tissues.

      There is a need for natural interventions that aid in the prevention and treatment of MetS
      risk factors as the prevalence of overnutrition and sedentary lifestyles continues to
      increase. This study will assess the ability of Oligopin® to improve abdominal obesity,
      fasting blood glucose, postprandial glucose and insulin response, and HDL-cholesterol levels
      as these outcomes reliably predict an individual's MetS risk. Oligopin® is a French Maritime
      Pine Bark Extract (FMPBE) obtained from the pine tree Pinus pinaster. It is rich in low
      molecular weight oligomeric procyanidins (OPC) with 20% of OPCs in the form of dimers as
      compared to the most studied FMPBE Pycogenol®, which contains only 5% of OPCs as dimers.

      Recently, Oligopin® supplementation was shown to reduce CVD risk factors. In a randomized,
      double-blind, placebo-controlled clinical trial, Oligopin® consumption increased HDL
      cholesterol levels and reduced systolic blood pressure and oxidized LDL (oxLDL) levels in
      stage 1 hypertensive individuals. This is significant as low HDL was reported to be the most
      prevalent risk factor for the development of MetS in young adults. FMPBE supplementation has
      also been shown to reduce fasting glucose levels in individuals with T2D. Interestingly,
      FMPBE is a potent inhibitor of α-glucosidase, which catalyses the breakdown of
      oligosaccharides in the small intestine to permit glucose resorption. Therefore, it is
      possible that Oligopin® may reduce fasting glucose levels and control postprandial
      hyperglycemia. This randomized, double-blind, placebo-controlled study will determine the
      efficacy of Oligopin® to improve markers of metabolic risk in subjects with MetS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fasting blood sugar level
time frame: 84 days
description: Change in fasting blood sugar from baseline to day 84 between Oligopin® and placebo.
measure: Fasting insulin concentration
time frame: Baseline, day 42 and day 84
description: Change in fasting insulin between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Fasting glucose level
time frame: Baseline, day 42 and day 84
description: Change in fasting glucose between Oligopin® and placebo baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Concentration of fasting low-density lipoprotein (LDL)
time frame: Baseline, day 42 and day 84
description: Change in fasting LDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Change in fasting oxidized LDL (oxLDL).
time frame: Baseline, day 42 and day 84
description: Change in fasting oxLDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Change in fasting high-density lipoprotein (HDL)
time frame: Baseline, day 42 and day 84
description: Change in fasting HDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Change in fasting total cholesterol
time frame: Baseline, day 42 and day 84
description: Change in fasting total cholesterol between Oligopin® and placebo baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Postprandial glucose at 20, 30, 90, or 120 min after meal
time frame: Baseline, day 42 and day 84
description: Change in postprandial glucose between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Postprandial insulin at 20, 30, 90, or 120 min after meal
time frame: Baseline, day 42 and day 84
description: Change in postprandial glucose between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: BMI
time frame: Baseline, day 42 and day 84
description: Change in BMI between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Waist circumference
time frame: Baseline, day 42 and day 84
description: Change in waist circumference between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Blood pressure
time frame: Baseline, day 42 and day 84
description: Change in systolic and diastolic blood pressure between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Heart rate
time frame: 84 days
description: Change in heart rate between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
measure: Alanine aminotransferase (ALT)
time frame: Pre-baseline and 84 days
description: Change in ALT between Oligopin® and placebo pre-baseline and day 84.
measure: Aspartate transaminase (AST)
time frame: Pre-baseline and 84 days
description: Change in AST between Oligopin® and placebo pre-baseline and day 84.
measure: Total bilirubin
time frame: Pre-baseline and 84 days
description: Change in total bilirubin between Oligopin® and placebo pre-baseline and day 84.
measure: Creatinine
time frame: Pre-baseline and 84 days
description: Change in creatinine between Oligopin® and placebo pre-baseline and day 84.
measure: Sodium ion
time frame: Pre-baseline and 84 days
description: Change in sodium ion between Oligopin® and placebo pre-baseline and day 84.
measure: Potassium ion
time frame: Pre-baseline and 84 days
description: Change in potassium ion between Oligopin® and placebo pre-baseline and day 84.
measure: Chloride ion
time frame: Pre-baseline and 84 days
description: Change in chloride ion between Oligopin® and placebo pre-baseline and day 84.
measure: estimated glomerular filtration rate (eGFR)
time frame: Pre-baseline and 84 days
description: Change in eGFR between Oligopin® and placebo pre-baseline and day 84.
measure: White blood cell (WBC) count
time frame: Pre-baseline and 84 days
description: Change in WBC count between Oligopin® and placebo pre-baseline and day 84.
measure: Neutrophils
time frame: Pre-baseline and 84 days
description: Change in neutrophil count between Oligopin® and placebo pre-baseline and day 84.
measure: Lymphocytes
time frame: Pre-baseline and 84 days
description: Change in lymphocyte count between Oligopin® and placebo pre-baseline and day 84.
measure: Monocytes
time frame: Pre-baseline and 84 days
description: Change in monocyte count between Oligopin® and placebo pre-baseline and day 84.
measure: Eosinophils
time frame: Pre-baseline and 84 days
description: Change in eosinophil count between Oligopin® and placebo pre-baseline and day 84.
measure: Basophils
time frame: Pre-baseline and 84 days
description: Change in basophil count between Oligopin® and placebo pre-baseline and day 84.
measure: Red blood cell (RBC)
time frame: Pre-baseline and 84 days
description: Change in RBC count between Oligopin® and placebo pre-baseline and day 84.
measure: Hemoglobin
time frame: Pre-baseline and 84 days
description: Change in hemoglobin level between Oligopin® and placebo pre-baseline and day 84.
measure: Hematocrit
time frame: Pre-baseline and 84 days
description: Change in hematocrit level between Oligopin® and placebo pre-baseline and day 84.
measure: Platelet
time frame: Pre-baseline and 84 days
description: Change in platelet count between Oligopin® and placebo pre-baseline and day 84.
measure: Mean corpuscular volume (MCV)
time frame: Pre-baseline and 84 days
description: Change in MCV level between Oligopin® and placebo pre-baseline and day 84.
measure: Mean corpuscular hemoglobin (MCH)
time frame: Pre-baseline and 84 days
description: Change in MCH level between Oligopin® and placebo pre-baseline and day 84.
measure: Mean corpuscular hemoglobin concentration (MCHC)
time frame: Pre-baseline and 84 days
description: Change in MCHC level between Oligopin® and placebo pre-baseline and day 84.
measure: Mean platelet volume (MPV)
time frame: Pre-baseline and 84 days
description: Change in MPV level between Oligopin® and placebo pre-baseline and day 84.
measure: Red cell distribution width (RDW)
time frame: Pre-baseline and 84 days
description: Change in RDW level between Oligopin® and placebo pre-baseline and day 84.
arm group label: Oligopin®
arm group type: Experimental
description: Oligopin® contains French Maritime Pine Bark Extract
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo is a mixture of different inert compounds
intervention type: Dietary Supplement
intervention name: Oligopin®
description: French Maritime Pine Bark Extract - 100mg/day
arm group label: Oligopin®
intervention type: Dietary Supplement
intervention name: Placebo
description: Maltodextrin
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Crowley, MD
role: Principal Investigator
affiliation: KGK Science Inc.
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No