Bariatric Surgery Candidate, Obesity
Conditions
Brief summary
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
Detailed description
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).
Interventions
Micronutriment supplementation therapy
Roux-en-Y gastric bypass provided in both arms.
Sponsors
Study design
Eligibility
Inclusion criteria
* Obesity BMI\>40 kg/m2
Exclusion criteria
* Antidepressant treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vitamins A levels | Change from Baseline at 6-months and 12-months post-RYGB |
| Vitamin E levels | Change from Baseline at 6-months and 12-months post-RYGB |
| Selenium levels | Change from Baseline at 6-months and 12-months post-RYGB |
| Zinc levels | Change from Baseline at 6-months and 12-months post-RYGB |
| Copper levels | Change from Baseline at 6-months and 12-months post-RYGB |
| Glutathione peroxidise | Change from Baseline at 6-months and 12-months post-RYGB |
| Superoxide dismutase | Change from Baseline at 6-months and 12-months post-RYGB |
| Iron levels | Change from Baseline at 6-months and 12-months post-RYGB |
Secondary
| Measure | Time frame |
|---|---|
| Alpha-linoleic acid (ALA) | 6-months and 12-months post-RYGB |
| Eicosapentaenoic acid (EPA) | 6-months and 12-months post-RYGB |
| Docosahexaenoic acid (DHA) | 6-months and 12-months post-RYGB |
| Total cholesterol | 6-months and 12-months post-RYGB |
| Anxiety (questionnaire HAD) | 6-months and 12-months post-RYGB |
| Depression (questionnaire HAD) | 6-months and 12-months post-RYGB |
| Quality of life (questionnaire IWQOL) | 6-months and 12-months post-RYGB |
| Gut microbiota modifications (sequencing the V4 region of 16S rDNA) | 6-months and 12-months post-RYGB |
| LDL-cholesterol | 6-months and 12-months post-RYGB |
| HDL-cholesterol | 6-months and 12-months post-RYGB |
| Triglycerides | 6-months and 12-months post-RYGB |
| Fasting glucose | 6-months and 12-months post-RYGB |
| Fasting insulin | 6-months and 12-months post-RYGB |
| C-Reactive Protein | 6-months and 12-months post-RYGB |
| Linoleic acid | 6-months and 12-months post-RYGB |
Countries
Switzerland