To identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects
Full Title of Study: “Next Generation Probiotics (NGPs) for Metabolic Health – Metagenomic Analysis to Identify NGP Candidates Correlated With Body Weight or Metabolic Markers”
- Study Type: Observational
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: October 1, 2016
- Other: observational
Arms, Groups and Cohorts
- BMI between 18−25
- BMI between 27.5−35
Clinical Trial Outcome Measures
- evaluate the differences in the intestinal microbiota profile between lean and obese subjects.
- Time Frame: 1 week
Participating in This Clinical Trial
2. Age between 20 to 50 years.
3. Obtained his/her informed consent after verbal and written information.
4. Sufficient general health and orientation for participating in the study as evaluated by the study personnel.
5. Have a high probability for compliance with and completion of the study.
6. Available for study visits and availability for food Confidential – Not to be copied Version 1.0 Date: 18 November 2015 DuPont/CRIM JB0004 – MFDU002 Page 8 of 42 recording.
7. Normal gastrointestinal function.
8. Willingness to provide faecal, urine and blood samples and keep food diary
Confidential – Not to be copied Version 1.0 Date: 18 November 2015 DuPont/CRIM JB0004 MFDU002 Page 9 of 42 Lactobacillus Rhamnosus GG or reuteri, bifidobacteria enriched products) in the past 6 weeks. 12. Use of anti-obesity drugs. 13. Active or recent (last 3 months) participation in a weight loss program including weight change (increase or loss) of 3 kg during the past three months. 14. Special diets e.g. Vegetarian, Vegan, Diets with intention to use certain limited food groups only (like paleo diet, egg-grape diet etc.) 15. History of chronic active inflammatory disorders. 16. History of bariatric surgery. 17. Regular use of non-steroidal anti-inflammatory drugs, corticosteroids, or equivalent immunomodulatory drugs. 18. Ongoing or recent (last 3 months) antibiotic treatment. 19. Immunosuppression or ongoing therapy causing immunosuppression. 20. Use of vitamin supplementations beyond Recommended Daily Intake levels during the previous 2 months and during the study, except for vitamin D supplementation up to 20 μg/day.
Gender Eligibility: Female
Minimum Age: 20 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Medfiles Ltd.
- Provider of Information About this Clinical Study
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