Next Generation Probiotics (NGPs) for Metabolic Health

NCT04229082 — Completed, 100 participants, Danisco

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Next Generation Probiotics (NGPs) for Metabolic Health - Metagenomic Analysis to Identify NGP Candidates Correlated With Body Weight or Metabolic Markers

Registry	NCT04229082
Status	Completed
Study type	Observational
Enrollment	100 (Actual)
Sponsor	Danisco (Industry); collaborators: Oy Medfiles Ltd, 4Pharma Ltd.
Conditions	Microbial Colonization
Interventions	observational (Other)
Dates	start 2016-04-08, primary completion 2016-10-01, completion 2017-06-09, first posted 2020-01-14, last updated 2020-01-27

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
lean		Other: observational	BMI between 18-25
obese		Other: observational	BMI between 27.5-35

observational (Other)

+Outcome measures

Primary outcomes

evaluate the differences in the intestinal microbiota profile between lean and obese subjects. [1 week]

+Eligibility

Sex: Female, ages: 20 Years to 50 Years, accepts healthy volunteers

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.