<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/NCT03029572</url>
  </required_header>
  <id_info>
    <org_study_id>08-005</org_study_id>
    <nct_id>NCT03029572</nct_id>
  </id_info>
  <brief_title>Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass</brief_title>
  <official_title>Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An intervention study design in 90 obese patients will be used. Nutritional, metabolic and&#xD;
      psychological status as well as gut microbiota will be evaluated before gastric bypass and 6&#xD;
      months post surgery. During this period of 6 months, all patients will receive a specific&#xD;
      diet according to recommendation with regard to bariatric surgery.&#xD;
&#xD;
      Subjects will be than randomized in 2 sub-groups:&#xD;
&#xD;
      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.&#xD;
      patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin&#xD;
      and mineral supplementation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of the study is to analyse the micro-nutritional status in morbidly obese&#xD;
      patients before and 6 months after bariatric surgery (Roux-en-Y gastric bypass, RYGB). The&#xD;
      secondary outcome will be the impact of 6 months probiotics, minerals, aminoacids, omega-3&#xD;
      acids and vitamin supplementation on microbiota, metabolic and psychological parameters 12&#xD;
      months post-RYGB.&#xD;
&#xD;
      An intervention study in 90 obese patients (BMI&gt;40 kg/m2) will be used. Nutritional,&#xD;
      metabolic and psychological status as well as gut microbiota will be evaluated before gastric&#xD;
      bypass and 6 months post RYGB. During this period of 6 months, all patients will receive a&#xD;
      specific diet according to recommendation with regard to RYGB.&#xD;
&#xD;
      Subjects will be than randomized in 2 sub-groups:&#xD;
&#xD;
      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.&#xD;
      patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin&#xD;
      and mineral supplementation Healthy diet will be defined as follow: 9-15% of proteins, 50-55%&#xD;
      of carbohydrates and 30-35% lipids (25% saturated fat, 50% mono-unsaturated fat and 25%&#xD;
      poly-unsaturated fat).&#xD;
&#xD;
      The following parameters will be analysed before RYGB and 6 months and 12 months post RYGB,&#xD;
      respectively:&#xD;
&#xD;
        -  Nutritional status with oxidative stress parameters (Vitamins A and E, Selenium, Zinc,&#xD;
           Copper, Glutathione peroxidise, Superoxide dismutase and Iron)&#xD;
&#xD;
        -  Metabolic parameters (Total cholesterol, LDL-cholesterol, HDL-cholesterol,&#xD;
           Triglycerides, fasting glucose and insulin, CRP)&#xD;
&#xD;
        -  Fatty acids (linoleic acid, alpha-linoleic acid (ALA), eicosapentaenoic acid (EPA), and&#xD;
           docosahexaenoic acid (DHA)&#xD;
&#xD;
        -  Gut microbiota&#xD;
&#xD;
        -  Psychological status (anxiety, depression and quality of life as evaluated by validated&#xD;
           questionnaires).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamins A levels</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin E levels</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Selenium levels</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Zinc levels</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Copper levels</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Glutathione peroxidise</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Superoxide dismutase</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron levels</measure>
    <time_frame>Change from Baseline at 6-months and 12-months post-RYGB</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-cholesterol</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting insulin</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linoleic acid</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alpha-linoleic acid (ALA)</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eicosapentaenoic acid (EPA)</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Docosahexaenoic acid (DHA)</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota modifications (sequencing the V4 region of 16S rDNA)</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety (questionnaire HAD)</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression (questionnaire HAD)</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (questionnaire IWQOL)</measure>
    <time_frame>6-months and 12-months post-RYGB</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Obesity</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Standard diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard healthy diet after RYGB surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Micro-nutriments' supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diet supplementation</intervention_name>
    <description>Micronutriment supplementation therapy</description>
    <arm_group_label>Micro-nutriments' supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery</intervention_name>
    <description>Roux-en-Y gastric bypass provided in both arms.</description>
    <arm_group_label>Micro-nutriments' supplementation</arm_group_label>
    <arm_group_label>Standard diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obesity BMI&gt;40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antidepressant treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospitals of Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1206</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Zoltan Pataky</investigator_full_name>
    <investigator_title>Deputy Head</investigator_title>
  </responsible_party>
  <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/NCT03029572
org study id: 08-005
nct id: NCT03029572
lead sponsor: 
has dmc: No
An intervention study design in 90 obese patients will be used. Nutritional, metabolic and
      psychological status as well as gut microbiota will be evaluated before gastric bypass and 6
      months post surgery. During this period of 6 months, all patients will receive a specific
      diet according to recommendation with regard to bariatric surgery.

      Subjects will be than randomized in 2 sub-groups:

      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.
      patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin
      and mineral supplementation
The primary aim of the study is to analyse the micro-nutritional status in morbidly obese
      patients before and 6 months after bariatric surgery (Roux-en-Y gastric bypass, RYGB). The
      secondary outcome will be the impact of 6 months probiotics, minerals, aminoacids, omega-3
      acids and vitamin supplementation on microbiota, metabolic and psychological parameters 12
      months post-RYGB.

      An intervention study in 90 obese patients (BMI>40 kg/m2) will be used. Nutritional,
      metabolic and psychological status as well as gut microbiota will be evaluated before gastric
      bypass and 6 months post RYGB. During this period of 6 months, all patients will receive a
      specific diet according to recommendation with regard to RYGB.

      Subjects will be than randomized in 2 sub-groups:

      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.
      patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin
      and mineral supplementation Healthy diet will be defined as follow: 9-15% of proteins, 50-55%
      of carbohydrates and 30-35% lipids (25% saturated fat, 50% mono-unsaturated fat and 25%
      poly-unsaturated fat).

      The following parameters will be analysed before RYGB and 6 months and 12 months post RYGB,
      respectively:

        -  Nutritional status with oxidative stress parameters (Vitamins A and E, Selenium, Zinc,
           Copper, Glutathione peroxidise, Superoxide dismutase and Iron)

        -  Metabolic parameters (Total cholesterol, LDL-cholesterol, HDL-cholesterol,
           Triglycerides, fasting glucose and insulin, CRP)

        -  Fatty acids (linoleic acid, alpha-linoleic acid (ALA), eicosapentaenoic acid (EPA), and
           docosahexaenoic acid (DHA)

        -  Gut microbiota

        -  Psychological status (anxiety, depression and quality of life as evaluated by validated
           questionnaires).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Vitamins A levels
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Vitamin E levels
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Selenium levels
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Zinc levels
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Copper levels
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Glutathione peroxidise
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Superoxide dismutase
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Iron levels
time frame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Total cholesterol
time frame: 6-months and 12-months post-RYGB
measure: LDL-cholesterol
time frame: 6-months and 12-months post-RYGB
measure: HDL-cholesterol
time frame: 6-months and 12-months post-RYGB
measure: Triglycerides
time frame: 6-months and 12-months post-RYGB
measure: Fasting glucose
time frame: 6-months and 12-months post-RYGB
measure: Fasting insulin
time frame: 6-months and 12-months post-RYGB
measure: C-Reactive Protein
time frame: 6-months and 12-months post-RYGB
measure: Linoleic acid
time frame: 6-months and 12-months post-RYGB
measure: Alpha-linoleic acid (ALA)
time frame: 6-months and 12-months post-RYGB
measure: Eicosapentaenoic acid (EPA)
time frame: 6-months and 12-months post-RYGB
measure: Docosahexaenoic acid (DHA)
time frame: 6-months and 12-months post-RYGB
measure: Gut microbiota modifications (sequencing the V4 region of 16S rDNA)
time frame: 6-months and 12-months post-RYGB
measure: Anxiety (questionnaire HAD)
time frame: 6-months and 12-months post-RYGB
measure: Depression (questionnaire HAD)
time frame: 6-months and 12-months post-RYGB
measure: Quality of life (questionnaire IWQOL)
time frame: 6-months and 12-months post-RYGB
arm group label: Standard diet
arm group type: Active Comparator
description: Standard healthy diet after RYGB surgery
arm group label: Micro-nutriments' supplementation
arm group type: Experimental
description: Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery
intervention type: Drug
intervention name: Diet supplementation
description: Micronutriment supplementation therapy
arm group label: Micro-nutriments' supplementation
intervention type: Procedure
intervention name: Bariatric surgery
description: Roux-en-Y gastric bypass provided in both arms.
arm group label: Micro-nutriments' supplementation
arm group label: Standard diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Zoltan Pataky
investigator title: Deputy Head
sharing ipd: No