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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Bariatric surgery; Drug: Diet 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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obesity BMI>40 kg/m2

Exclusion Criteria:

• Antidepressant treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 14, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 08-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO