Next Generation Probiotics (NGPs) for Metabolic Health

Danisco

Status

Completed

Conditions

Microbial Colonization

Treatments

Other: observational

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT04229082

MFDU002

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Females.
Age between 20 to 50 years.
Obtained his/her informed consent after verbal and written information.
Sufficient general health and orientation for participating in the study as evaluated by the study personnel.
Have a high probability for compliance with and completion of the study.
Available for study visits and availability for food
Normal gastrointestinal function.
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.