Effect of Oral 6-bromotryptophan on Safety, Pharmacokinetics and Efficacy in Metabolic Syndrome Individuals
NCT05971524 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2023-08-22
Summary
Safety, pharmacokinetics and efficacy of a novel endogenous plasma metabolite, 6-bromotryptophan, will be established in metabolic syndrome/ insulin resistant participants.
Conditions
- Metabolic Syndrome
- Diabetes Mellitus
Interventions
- DIETARY_SUPPLEMENT
-
6-BT
2,4 or 8mg of 6-BT once daily for 4 weeks
- DIETARY_SUPPLEMENT
-
Placebo
A placebo capsule once daily for 4 weeks
Sponsors & Collaborators
-
Nordin Hanssen
lead OTHER
Principal Investigators
-
Nordin MJ Hanssen, dr. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-04
- Primary Completion
- 2025-02-01
- Completion
- 2025-02-01
Countries
- Netherlands
Study Locations
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