Clinical trial NCT03029572: Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass
Official title: Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bariatric Surgery Candidate
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Obesity BMI\>40 kg/m2

Exclusion Criteria:

* Antidepressant treatment

Primary outcomes:
measure: Vitamins A levels
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Vitamin E levels
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Selenium levels
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Zinc levels
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Copper levels
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Glutathione peroxidise
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Superoxide dismutase
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
measure: Iron levels
timeFrame: Change from Baseline at 6-months and 12-months post-RYGB
Secondary outcomes:
measure: Total cholesterol
timeFrame: 6-months and 12-months post-RYGB
measure: LDL-cholesterol
timeFrame: 6-months and 12-months post-RYGB
measure: HDL-cholesterol
timeFrame: 6-months and 12-months post-RYGB
measure: Triglycerides
timeFrame: 6-months and 12-months post-RYGB
measure: Fasting glucose
timeFrame: 6-months and 12-months post-RYGB
measure: Fasting insulin
timeFrame: 6-months and 12-months post-RYGB
measure: C-Reactive Protein
timeFrame: 6-months and 12-months post-RYGB
measure: Linoleic acid
timeFrame: 6-months and 12-months post-RYGB
measure: Alpha-linoleic acid (ALA)
timeFrame: 6-months and 12-months post-RYGB
measure: Eicosapentaenoic acid (EPA)
timeFrame: 6-months and 12-months post-RYGB
measure: Docosahexaenoic acid (DHA)
timeFrame: 6-months and 12-months post-RYGB
measure: Gut microbiota modifications (sequencing the V4 region of 16S rDNA)
timeFrame: 6-months and 12-months post-RYGB
measure: Anxiety (questionnaire HAD)
timeFrame: 6-months and 12-months post-RYGB
measure: Depression (questionnaire HAD)
timeFrame: 6-months and 12-months post-RYGB
measure: Quality of life (questionnaire IWQOL)
timeFrame: 6-months and 12-months post-RYGB
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
References: