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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard diet | Active Comparator | Standard healthy diet after RYGB surgery |
|
| Micro-nutriments' supplementation | Experimental | Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet supplementation | Drug | Micronutriment supplementation therapy |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | 6-months and 12-months post-RYGB | |
| LDL-cholesterol | 6-months and 12-months post-RYGB | |
| HDL-cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva | Geneva | 1206 | Switzerland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Bariatric surgery |
| Procedure |
Roux-en-Y gastric bypass provided in both arms. |
|
| 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 |
| 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 |
| Gut microbiota modifications (sequencing the V4 region of 16S rDNA) | 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |