Exploring a Natural Solution for Childhood Obesity

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

August 1, 2026

Study Completion Date

December 31, 2026

Conditions
ObesityChildren
Interventions
DRUG

genistein

Participants will receive genistein treatment (10-15 mg/kg/day with a maximum dose of 1500mg/day) for 3 months. From the 3-month- to 6-month follow-up, participants will receive a dose of 20-25 mg/kg/day (with a maximum dose of 1500mg/day). According to participant preference, Genistein will be provided as a capsule (250mg per capsule). For participants that are unable to swallow the capsule the capsule may be opened and the powder from the capsule can be mixed with a beverage or food. Interim clinical evaluations will occur at 3 and 6 months to assess, tolerability, adherence and efficacy.. Post-treatment assessment after a 3-month washout will occur at 9 months to determine delayed adverse effects and persistence of beneficial effects after genistein discontinuation.

All Listed Sponsors
collaborator

Western University, Canada

OTHER

collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

lead

Western University

OTHER

NCT07033767 - Exploring a Natural Solution for Childhood Obesity | Biotech Hunter | Biotech Hunter