Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
NCT06502834 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-07-16
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.
Conditions
- Obesity
- Metabolic Syndrome
- Steatosis of Liver
Interventions
- DIETARY_SUPPLEMENT
-
D piger
Probiotic d piger
- DIETARY_SUPPLEMENT
-
Placebo
Placebo
Sponsors & Collaborators
-
Max Nieuwdorp
lead OTHER
Principal Investigators
-
Max Nieuwdorp, prof dr · Amsterdam UMC, location AMC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2024-12-01
- Completion
- 2024-12-01
Countries
- Netherlands
Study Locations
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