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

RECRUITINGPhase 1Sponsored by Max Nieuwdorp
Actively Recruiting
PhasePhase 1
SponsorMax Nieuwdorp
Started2024-05-01
Est. completion2024-12-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06502834

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions4

Liver DiseaseMetabolic SyndromeObesitySteatosis of Liver

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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