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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029572
• Other study ID #: 08-005
• Status: Completed
• Phase: N/A
• First received: January 14, 2017
• Last updated: January 19, 2017
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Obesity BMI>40 kg/m2

Exclusion Criteria:

• Antidepressant treatment

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Intervention

Drug:
• Diet supplementation
Micronutriment supplementation therapy

Procedure:
• Bariatric surgery
Roux-en-Y gastric bypass provided in both arms.

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamins A levels		Change from Baseline at 6-months and 12-months post-RYGB
Primary	Vitamin E levels		Change from Baseline at 6-months and 12-months post-RYGB
Primary	Selenium levels		Change from Baseline at 6-months and 12-months post-RYGB
Primary	Zinc levels		Change from Baseline at 6-months and 12-months post-RYGB
Primary	Copper levels		Change from Baseline at 6-months and 12-months post-RYGB
Primary	Glutathione peroxidise		Change from Baseline at 6-months and 12-months post-RYGB
Primary	Superoxide dismutase		Change from Baseline at 6-months and 12-months post-RYGB
Primary	Iron levels		Change from Baseline at 6-months and 12-months post-RYGB
Secondary	Total cholesterol		6-months and 12-months post-RYGB
Secondary	LDL-cholesterol		6-months and 12-months post-RYGB
Secondary	HDL-cholesterol		6-months and 12-months post-RYGB
Secondary	Triglycerides		6-months and 12-months post-RYGB
Secondary	Fasting glucose		6-months and 12-months post-RYGB
Secondary	Fasting insulin		6-months and 12-months post-RYGB
Secondary	C-Reactive Protein		6-months and 12-months post-RYGB
Secondary	Linoleic acid		6-months and 12-months post-RYGB
Secondary	Alpha-linoleic acid (ALA)		6-months and 12-months post-RYGB
Secondary	Eicosapentaenoic acid (EPA)		6-months and 12-months post-RYGB
Secondary	Docosahexaenoic acid (DHA)		6-months and 12-months post-RYGB
Secondary	Gut microbiota modifications (sequencing the V4 region of 16S rDNA)		6-months and 12-months post-RYGB
Secondary	Anxiety (questionnaire HAD)		6-months and 12-months post-RYGB
Secondary	Depression (questionnaire HAD)		6-months and 12-months post-RYGB
Secondary	Quality of life (questionnaire IWQOL)		6-months and 12-months post-RYGB