Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation

Conditions
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Obesity, Bariatric Surgery Candidate

Intervention / Treatment
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* Drug: Diet supplementation
* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity BMI>40 kg/m2 Exclusion Criteria: Antidepressant treatment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard diet<br>Standard healthy diet after RYGB surgery | Procedure: Bariatric surgery<br>* Roux-en-Y gastric bypass provided in both arms.<br>|
| Experimental: Micro-nutriments' supplementation<br>Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery | Drug: Diet supplementation<br>* Micronutriment supplementation therapy<br>Procedure: Bariatric surgery<br>* Roux-en-Y gastric bypass provided in both arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol |  | 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 | 
| 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 |