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Recruiting Phase 1 NCT06502834

Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)

Trial Parameters

Condition Obesity
Sponsor Max Nieuwdorp
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-05-01
Completion 2024-12-01
Interventions
D pigerPlacebo

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 trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.

Eligibility Criteria

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

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