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OpenTrials
Completed

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

Completed

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Key information

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

Observational

Other

Primary outcomes

  1. 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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