Effect of D. Piger on Ethanol Metabolism in Overweight Individuals
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
This study is testing whether a daily supplement called D. Piger can help overweight people process alcohol better over four weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06502834 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a daily oral supplement of D. Piger on ethanol metabolism in overweight individuals over a four-week period. Participants will be randomly assigned to receive either the D. Piger supplement or a placebo, with assessments conducted at baseline and after the intervention. The study will include safety visits and various tests, including a fructose challenge test and imaging of the liver, to evaluate the effects on blood ethanol levels and intestinal health. The aim is to understand how this supplement may influence metabolic processes in individuals with impaired glucose tolerance.
Who should consider this trial
Good fit: Ideal candidates are overweight males and females aged 18-70 with impaired glucose tolerance and increased waist circumference.
Not a fit: Patients with a history of cardiovascular events, gastrointestinal diseases, or those currently using systemic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into new dietary interventions for improving metabolic health in overweight individuals.
How similar studies have performed: While there is limited data on the specific effects of D. Piger, similar studies on gut microbiota and metabolic health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- Amsterdam UMC location AMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Max Nieuwdorp, prof dr — Amsterdam UMC, location AMC
- Study coordinator: M Nieuwdorp, prof dr
- Email: m.nieuwdorp@amsterdamumc.nl
- Phone: 020-5669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.