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

No results posted yet for this study

Summary

Safety, pharmacokinetics and efficacy of a novel endogenous plasma metabolite, 6-bromotryptophan, will be established in metabolic syndrome/ insulin resistant participants.

Conditions

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971524 on ClinicalTrials.gov