Actively Recruiting
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Led by Max Nieuwdorp · Updated on 2024-07-16
20
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight. The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.
CONDITIONS
Official Title
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or postmenopausal female
- Increased waist circumference (>102 cm for men, >88 cm for women)
- Insulin resistance (HOMA >2.5)
- Age between 18 and 70 years
You will not qualify if you...
- Use of systemic medication (except paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study
- History of cardiovascular event
- History of cholecystectomy
- Untreated gastrointestinal disease or abnormal bowel habits
- Liver enzymes more than 2.5 times above the normal range
- Smoking
- Alcohol abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC location AMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
M
M Nieuwdorp, prof dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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