Effect of 6-bromotryptophan on metabolic syndrome
Effect of 4 Weeks of Oral 6-bromotryptophan on Safety, Pharmacokinetics and Efficacy in Metabolic Syndrome Individuals (2022)
This study is testing if a new supplement called 6-bromotryptophan can help people with metabolic syndrome or insulin resistance manage their blood sugar and overall health better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | Male |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT05971524 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety, pharmacokinetics, and efficacy of a novel metabolite, 6-bromotryptophan (6-BT), in individuals with metabolic syndrome or insulin resistance. Participants aged 35-70 will receive either a placebo or varying doses of 6-BT capsules daily for four weeks in a double-blind, placebo-controlled design. The study aims to assess the tolerability of 6-BT while monitoring its effects on glucose homeostasis and other biochemical parameters. If proven safe, 6-BT may serve as a beneficial food supplement for managing diabetes.
Who should consider this trial
Good fit: Ideal candidates are Caucasian males aged 35-70 with metabolic syndrome or insulin resistance who are not on systemic medications.
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 a new dietary supplement option for individuals with metabolic syndrome and diabetes.
How similar studies have performed: While the approach of using 6-BT is novel, preliminary studies have shown promise in related conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Metabolic syndrome, defined as: - ≥3 criteria out of the 5 following criteria: * fasting plasma glucose ≥5.6 mmol/L * triglycerides ≥1.7 mmol/L * waist circumference ≥102 cm * high-density lipoprotein cholesterol ≤1.04 mmol/ * blood pressure ≥130/85 mm Hg. AND/ OR Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (\>2.5) * Male * Caucasian * 35-70 years old Exclusion Criteria: * Use of systemic medication (except for paracetamol), including proton pump inhibitors, 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 * Exclusion criterion for MRI liver (see E4_BROMO_vragenlijst MRI) * Alcohol abuse
Where this trial is running
Amsterdam, Noord-Holland
- Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nordin MJ Hanssen, dr. — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Nordin MJ Hanssen, dr.
- Email: n.m.j.hanssen@amsterdamumc.nl
- Phone: 020-56691111
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.