Next Generation Probiotics (NGPs) for Metabolic Health

NCT04229082 | Completed

• 1 other identifier: MFDU002
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• evaluate the differences in the intestinal microbiota profile between lean and obese subjects.

  1 week

Study Arms (2)

lean

BMI between 18-25

Other: observational

obese

BMI between 27.5-35

Other: observational

Interventions

observational OTHER

lean; obese

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

General adult population

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danisco: lead
• Oy Medfiles Ltd: collaborator
• 4Pharma Ltd.: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Fecal, urine, blood

MeSH Terms

Conditions

Communicable Diseases

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: April 8, 2016
• Primary Completion: October 1, 2016
• Study Completion: June 9, 2017
• Last Updated: January 27, 2020

Record last verified: 2020-01