Next Generation Probiotics (NGPs) for Metabolic Health

NCT ID: NCT04229082

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-08

Study Completion Date

2017-06-09

Brief Summary

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

Detailed Description

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Conditions

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Microbial Colonization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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lean

BMI between 18-25

observational

Intervention Type OTHER

obese

BMI between 27.5-35

observational

Intervention Type OTHER

Interventions

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observational

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oy Medfiles Ltd

INDUSTRY

Sponsor Role collaborator

4Pharma Ltd.

INDUSTRY

Sponsor Role collaborator

Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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MFDU002

Identifier Type: -

Identifier Source: org_study_id

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