NCT07033767Not yet recruitingPhase 1/2
Exploring a Natural Solution for Childhood Obesity
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Western University
- Diseases
- Obesity
- NCT number
- NCT07033767
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 1 Aug 2025 to the primary completion date, 1 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of medications that may confound study outcomes, including:
- ADHD medications (e.g., Concerta, Vyvanse, Abilify)
- Antipsychotic medications (e.g., Risperidone)
Other illness
- Known allergy to Sophora japonica (source of genistein).
- Diagnosis of type 2 diabetes (these patients are followed in a separate Diabetes Clinic).
Other
- GLP-1 receptor agonists (e.g., Saxenda, Wegovy)
- Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
Who the study is looking for
- 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.
Age in the registry: 4 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.