Next Generation Probiotics (NGPs) for Metabolic Health

Completed

• Conditions: Microbial Colonization
• Interventions: Other: observational

• Registration Number: NCT04229082
• Lead Sponsor: Danisco

Brief Summary

To identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-08
• Primary Completion: 2016-10-01
• Study Completion: 2017-06-09
• Status Verified: 2020-01
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-14
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lean	observational	BMI between 18-25
obese	observational	BMI between 27.5-35

Primary Outcome Measures

Name	Time	Method
evaluate the differences in the intestinal microbiota profile between lean and obese subjects.	1 week