Exploring a Natural Solution for Childhood Obesity

NCT07033767 | Not Yet Recruiting Phase 1

• 1 other identifier: 125367
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

genistein; childhood obesity; children

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI) z-score

  To assess the impact of genistein on Body Mass Index (BMI) z-scores, calculated using the World Health Organization (WHO) growth reference standards for age and sex. Scale: WHO BMI-for-age z-score Score Range: Typically from approximately -3 to +5 Interpretation: Higher scores indicate greater degrees of obesity, and lower scores indicate improvement in weight status relative to age and sex norms.

  6 months

Secondary Outcomes (2)

• Tolerability of Genistein Treatment

  6 months

• Adherence to Genistein Treatment

  6 months

Other Outcomes (9)

• Change in Fasting Glucose Levels

  6 months

• Change in Fasting Insulin Levels

  6 months

• Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)

  6 months

Study Arms (1)

single arm study

OTHER

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)

Drug: genistein

Interventions

genistein 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.

single arm study

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University: lead
• Western University, Canada: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Interventions

Genistein

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marina Ybarra, MD, MSc

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Ybarra, MD, MSc

CONTACT

+15196858500; marina.ybarra@lhsc.on.ca

Mylene Trojman

CONTACT

+15196858500; healprogram@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc - Assistant Professor

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share