Exploring a Natural Solution for Childhood Obesity

Launched by WESTERN UNIVERSITY · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a natural substance called genistein can help treat obesity in children and teenagers aged 4 to 17 years. The main goal is to see if genistein is safe, easy to take, and well-tolerated by young patients with obesity. The study will also look at whether genistein can help lower body weight, measured by a special score called BMI z-score, and improve heart and metabolic health, such as reducing inflammation and improving blood pressure and cholesterol.

Children and teens who have obesity and are already part of a healthy lifestyle program at the Children's Hospital in London, Ontario, may be eligible to join. Participants will take genistein for six months, with health check-ups at three and six months to see how well the treatment is working and to make sure it’s safe. After stopping the treatment, there will be one more check-up three months later to see if any benefits last. Blood and urine tests will be done throughout the study to track health changes and confirm the medication is being taken correctly. The study aims to include about 60 participants and hopes to provide important information that could lead to better treatments for childhood obesity in the future.

Gender

ALL

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.