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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Micronutriment supplementation therapy
Roux-en-Y gastric bypass provided in both arms.
University Hospitals of Geneva
Geneva, Switzerland
Vitamins A levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Vitamin E levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Selenium levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Zinc levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Copper levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Glutathione peroxidise
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Superoxide dismutase
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Iron levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Total cholesterol
Time frame: 6-months and 12-months post-RYGB
LDL-cholesterol
Time frame: 6-months and 12-months post-RYGB
HDL-cholesterol
Time frame: 6-months and 12-months post-RYGB
Triglycerides
Time frame: 6-months and 12-months post-RYGB
Fasting glucose
Time frame: 6-months and 12-months post-RYGB
Fasting insulin
Time frame: 6-months and 12-months post-RYGB
C-Reactive Protein
Time frame: 6-months and 12-months post-RYGB
Linoleic acid
Time frame: 6-months and 12-months post-RYGB
Alpha-linoleic acid (ALA)
Time frame: 6-months and 12-months post-RYGB
Eicosapentaenoic acid (EPA)
Time frame: 6-months and 12-months post-RYGB
Docosahexaenoic acid (DHA)
Time frame: 6-months and 12-months post-RYGB
Gut microbiota modifications (sequencing the V4 region of 16S rDNA)
Time frame: 6-months and 12-months post-RYGB
Anxiety (questionnaire HAD)
Time frame: 6-months and 12-months post-RYGB
Depression (questionnaire HAD)
Time frame: 6-months and 12-months post-RYGB
Quality of life (questionnaire IWQOL)
Time frame: 6-months and 12-months post-RYGB
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