Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass
NCT ID: NCT03029572
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2009-02-28
2012-12-31
Brief Summary
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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
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard diet
Standard healthy diet after RYGB surgery
Bariatric surgery
Roux-en-Y gastric bypass provided in both arms.
Micro-nutriments' supplementation
Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery
Diet supplementation
Micronutriment supplementation therapy
Bariatric surgery
Roux-en-Y gastric bypass provided in both arms.
Interventions
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Diet supplementation
Micronutriment supplementation therapy
Bariatric surgery
Roux-en-Y gastric bypass provided in both arms.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
60 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Zoltan Pataky
Deputy Head
Locations
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University Hospitals of Geneva
Geneva, , Switzerland
Countries
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Other Identifiers
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08-005
Identifier Type: -
Identifier Source: org_study_id
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