Next Generation Probiotics (NGPs) for Metabolic Health

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

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

Study Overview

• Status: Completed
• Conditions: Microbial Colonization
• Intervention / Treatment: Other: observational

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

General adult population

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lean; BMI between 18-25	Other: observational
obese; BMI between 27.5-35	Other: observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluate the differences in the intestinal microbiota profile between lean and obese subjects.	1 week

Collaborators and Investigators

• Sponsor: Danisco
• Collaborators: 4Pharma Ltd.; Medfiles Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): June 9, 2017

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: MFDU002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No