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

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Obesity
• Interventions: Procedure: Bariatric surgery; Drug: Diet supplementation

• Registration Number: NCT03029572
• Lead Sponsor: University Hospital, Geneva

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).

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-14
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-24
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Obesity BMI>40 kg/m2

Exclusion Criteria

• Antidepressant treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard diet	Bariatric surgery	Standard healthy diet after RYGB surgery
Micro-nutriments' supplementation	Diet supplementation	Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery
Micro-nutriments' supplementation	Bariatric surgery	Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery

Primary Outcome Measures

Name	Time	Method
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
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
Copper levels	Change from Baseline at 6-months and 12-months post-RYGB

Secondary Outcome Measures

Name	Time	Method
Triglycerides	6-months and 12-months post-RYGB
Fasting glucose	6-months and 12-months post-RYGB
LDL-cholesterol	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
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
Total cholesterol	6-months and 12-months post-RYGB
HDL-cholesterol	6-months and 12-months post-RYGB
Fasting insulin	6-months and 12-months post-RYGB
Alpha-linoleic acid (ALA)	6-months and 12-months post-RYGB
Quality of life (questionnaire IWQOL)	6-months and 12-months post-RYGB

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland