RECRUITINGPhase 1INTERVENTIONAL
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
About This Trial
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.
Who May Be Eligible (Plain English)
Inclusion:
Male or (postmenopausal) females
- Increased waist circumference (\>102 cm men, 88\>cm women)
- Insulin resistance (HOMA\>2.5)
- 18-70 years
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIETARY_SUPPLEMENT
D piger
Probiotic d piger
DIETARY_SUPPLEMENT
Placebo
Placebo
Locations (1)
Amsterdam UMC location AMC
Amsterdam, Netherlands