RecruitingPhase 1NCT06502834
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Sponsor
Max Nieuwdorp
Enrollment
20 participants
Start Date
May 1, 2024
Study Type
INTERVENTIONAL
Conditions
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 trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria4
- Male or (postmenopausal) females
- Increased waist circumference (>102 cm men, 88>cm women)
- Insulin resistance (HOMA>2.5)
- -70 years
Exclusion Criteria7
- 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
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Interventions
DIETARY_SUPPLEMENTD piger
Probiotic d piger
DIETARY_SUPPLEMENTPlacebo
Placebo
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06502834
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