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Completed

NCT Number: NCT03029572

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

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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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Geneva

Geneva, 1206, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obesity BMI>40 kg/m2

Exclusion criteria

  • Antidepressant treatment

Treatment and study plan

Diet supplementation

Drug

Micronutriment supplementation therapy

bariatric surgery

Procedure

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

Primary outcomes

  1. Vitamins A levels

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

  2. Vitamin E levels

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

  3. Selenium levels

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

  4. Zinc levels

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

  5. Copper levels

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

  6. Glutathione peroxidise

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

  7. Superoxide dismutase

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

  8. Iron levels

    Time frame: Change from Baseline at 6-months and 12-months post-RYGB

Secondary outcomes

  1. Total cholesterol

    Time frame: 6-months and 12-months post-RYGB

  2. LDL-cholesterol

    Time frame: 6-months and 12-months post-RYGB

  3. HDL-cholesterol

    Time frame: 6-months and 12-months post-RYGB

  4. Triglycerides

    Time frame: 6-months and 12-months post-RYGB

  5. Fasting glucose

    Time frame: 6-months and 12-months post-RYGB

  6. Fasting insulin

    Time frame: 6-months and 12-months post-RYGB

  7. C-Reactive Protein

    Time frame: 6-months and 12-months post-RYGB

  8. Linoleic acid

    Time frame: 6-months and 12-months post-RYGB

  9. Alpha-linoleic acid (ALA)

    Time frame: 6-months and 12-months post-RYGB

  10. Eicosapentaenoic acid (EPA)

    Time frame: 6-months and 12-months post-RYGB

  11. Docosahexaenoic acid (DHA)

    Time frame: 6-months and 12-months post-RYGB

  12. Gut microbiota modifications (sequencing the V4 region of 16S rDNA)

    Time frame: 6-months and 12-months post-RYGB

  13. Anxiety (questionnaire HAD)

    Time frame: 6-months and 12-months post-RYGB

  14. Depression (questionnaire HAD)

    Time frame: 6-months and 12-months post-RYGB

  15. Quality of life (questionnaire IWQOL)

    Time frame: 6-months and 12-months post-RYGB

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 24, 2017
Registry last updated
Jan 24, 2017

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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