Status:
RECRUITING
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Lead Sponsor:
Max Nieuwdorp
Conditions:
Obesity
Metabolic Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
The investigators perform a randomized, placebo controlled trial in 2x10 participants. The participants will be given placebo or d piger as an oral suspension once daily for 30 days. At baseline and...
Eligibility Criteria
Inclusion
- Inclusion:
- Male or (postmenopausal) females
- Increased waist circumference (\>102 cm men, 88\>cm women)
- Insulin resistance (HOMA\>2.5)
- 18-70 years
- Exclusion Criteria:
- Use of systemic medication (except for paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study period.
- A history of a cardiovascular event
- A history of cholecystectomy
- Overt untreated gastrointestinal disease or abnormal bowel habits
- Liver enzymes\>2.5 fold higher than the upper limit of normal range
- Smoking
- Alcohol abuse
Exclusion
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06502834
Start Date
May 1 2024
End Date
December 1 2024
Last Update
July 16 2024
Active Locations (1)
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1
Amsterdam UMC location AMC
Amsterdam, Netherlands