NCT Number: NCT04229082
Next Generation Probiotics (NGPs) for Metabolic Health
To identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects
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Notify MeKey information
Conditions
Age range
20 year–50 year
Sex eligibility
Female
Study type
Observational
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
evaluate the differences in the intestinal microbiota profile between lean and obese subjects.
Time frame: 1 week
Sponsors and collaborators
Lead sponsor
Danisco
Industry
Collaborators
- 4Pharma Ltd.
- Oy Medfiles Ltd
Registry information
Official study title
Next Generation Probiotics (NGPs) for Metabolic Health - Metagenomic Analysis to Identify NGP Candidates Correlated With Body Weight or Metabolic Markers
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Jan 14, 2020
- Registry last updated
- Jan 27, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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