Next Generation Probiotics (NGPs) for Metabolic Health

Overview

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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 1, 2016

Interventions

  • Other: observational

Arms, Groups and Cohorts

  • lean
    • BMI between 18−25
  • obese
    • BMI between 27.5−35

Clinical Trial Outcome Measures

Primary Measures

  • evaluate the differences in the intestinal microbiota profile between lean and obese subjects.
    • Time Frame: 1 week

Participating in This Clinical Trial

Inclusion Criteria

1. Females.

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

7. Normal gastrointestinal function.

8. Willingness to provide faecal, urine and blood samples and keep food diary

Exclusion Criteria

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

Investigator Details

  • Lead Sponsor
    • Danisco
  • Collaborator
    • Medfiles Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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