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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03029572
Enrollment
90
Registered
2017-01-24
Start date
2009-02-28
Completion date
2012-12-31
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Obesity

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).

Interventions

Micronutriment supplementation therapy

PROCEDUREBariatric surgery

Roux-en-Y gastric bypass provided in both arms.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Obesity BMI\>40 kg/m2

Exclusion criteria

* Antidepressant treatment

Design outcomes

Primary

MeasureTime frame
Vitamins A levelsChange from Baseline at 6-months and 12-months post-RYGB
Vitamin E levelsChange from Baseline at 6-months and 12-months post-RYGB
Selenium levelsChange from Baseline at 6-months and 12-months post-RYGB
Zinc levelsChange from Baseline at 6-months and 12-months post-RYGB
Copper levelsChange from Baseline at 6-months and 12-months post-RYGB
Glutathione peroxidiseChange from Baseline at 6-months and 12-months post-RYGB
Superoxide dismutaseChange from Baseline at 6-months and 12-months post-RYGB
Iron levelsChange from Baseline at 6-months and 12-months post-RYGB

Secondary

MeasureTime frame
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
Total cholesterol6-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
Gut microbiota modifications (sequencing the V4 region of 16S rDNA)6-months and 12-months post-RYGB
LDL-cholesterol6-months and 12-months post-RYGB
HDL-cholesterol6-months and 12-months post-RYGB
Triglycerides6-months and 12-months post-RYGB
Fasting glucose6-months and 12-months post-RYGB
Fasting insulin6-months and 12-months post-RYGB
C-Reactive Protein6-months and 12-months post-RYGB
Linoleic acid6-months and 12-months post-RYGB

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026