NCT06502834 Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
| NCT ID | NCT06502834 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Max Nieuwdorp |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-05-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Max Nieuwdorp, prof dr
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location AMC
Frequently Asked Questions
Who can join the NCT06502834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06502834 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06502834 currently recruiting?
Yes, NCT06502834 is actively recruiting participants. Contact the research team at m.nieuwdorp@amsterdamumc.nl for enrollment information.
Where is the NCT06502834 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06502834 clinical trial?
NCT06502834 is sponsored by Max Nieuwdorp. The principal investigator is Max Nieuwdorp, prof dr at Amsterdam UMC, location AMC. The trial plans to enroll 20 participants.
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