University Hospitals of Geneva
Geneva, 1206, Switzerland
NCT Number: NCT03029572
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
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Geneva, 1206, Switzerland
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Micronutriment supplementation therapy
Roux-en-Y gastric bypass provided in both arms.
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
Time frame: 6-months and 12-months post-RYGB
University Hospital, Geneva
Other
Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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