Exploring a Natural Solution for Childhood Obesity

NCT ID: NCT07033767

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-31

Brief Summary

This study aims to assess the safety tolerability, adherence and effectiveness of genistein as an anti-obesity treatment for children and adolescents. The primary goal is determining how well genistein is tolerated and adhered to by pediatric patients with obesity. Secondary goals include evaluating its impact on body mass index z-scores and cardiometabolic risk factors, such as inflammation.

Participants aged 4-18 will be recruited from the Paediatric HEAL (Healthy Eating, Activity & Lifestyle) Program at the Children's Hospital - London Health Science Center in London, Ontario. They will receive genistein treatment over 6 months, with interim assessments at 3 and 6 months to monitor efficacy, safetytolerability, and adherence, and efficacy, and potentially increase the dose at the 3-month visit. A final assessment will occur after a 3-month washout to observe any lasting effects.

Blood and urine samples will be collected to analyze various adherence and health markers, including inflammatory and cardiometabolic factors. For participants who are of childbearing potential and have had their first menses, the blood analysis will also include pregnancy testing. Laboratory testing will be performed at baseline, at three and six months while taking genistein and three months after the washout period. Urine samples will also confirm that genistein has been taken appropriately throughout the study.

The study expects that genistein will be well-tolerated by children, reduce BMI z-scores by 0.2 (0.5), and improve cardiometabolic risk factors such as blood pressure, lipid profiles, and inflammation. A sample size of 60 participants has been calculated to achieve statistically significant results, which will inform more extensive studies on genistein's potential for managing pediatric obesity.

Conditions

Obesity; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm study

Arm Type: Single Group Assignment

Assigned Intervention:

Drug: Genistein

Participants will receive genistein at 10-15 mg/kg/day (max 1500 mg/day) for the first 3 months.

From months 3 to 6, the dose will be increased to 20-25 mg/kg/day (max 1500 mg/day).

Genistein will be provided as 250 mg capsules. Capsules may be swallowed whole or opened and mixed with food or a beverage for those unable to swallow pills.

Interim evaluations will be conducted at 3 and 6 months to assess tolerability, adherence, and efficacy.

A post-treatment follow-up at 9 months (after a 3-month washout) will assess delayed adverse effects and the persistence of benefits after genistein discontinuation.

Other Names:

Sophora japonica extract

Genistin (active metabolite)

Group Type: OTHER

genistein

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children and adolescents aged 4-17 years.
• Obesity defined as a BMI z-score ≥ 2 for age and sex, based on World Health Organization (WHO) reference standards.
• Stable or increasing BMI after at least 3 months of enrollment in the HEAL program.
• Inclusion of participants from all backgrounds, consistent with principles of equity, diversity, and inclusion.
• Participants and families who do not speak or read English will be included, provided interpreter services are available at LHSC's Children's Hospital.
• Participants who decline to enroll will continue receiving standard care in the HEAL program.

Exclusion Criteria

• Known allergy to Sophora japonica (source of genistein).
• Diagnosis of type 2 diabetes (these patients are followed in a separate Diabetes Clinic).
• Current use of medications that may confound study outcomes, including:
• GLP-1 receptor agonists (e.g., Saxenda, Wegovy)
• ADHD medications (e.g., Concerta, Vyvanse, Abilify)
• Antipsychotic medications (e.g., Risperidone)
• Currently pregnant, breastfeeding, or planning to become pregnant during the study period.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

Western University

OTHER

Sponsor Role: lead

Responsible Party

Marina Ybarra

MD, MSc - Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marina Ybarra, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Western University

Central Contacts

Marina Ybarra, MD, MSc

Role: CONTACT

marina.ybarra@lhsc.on.ca

+15196858500 ext. 75751

Mylene Trojman

Role: CONTACT

healprogram@lhsc.on.ca

+15196858500 ext. 75111

Other Identifiers

125367

Identifier Type: -

Identifier Source: org_study_id