Exploring a Natural Solution for Childhood Obesity
- Registration Number
- NCT07033767
- Lead Sponsor
- Western University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm study genistein 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)
- Primary Outcome Measures
Name Time Method Change in Body Mass Index (BMI) z-score 6 months 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.
- Secondary Outcome Measures
Name Time Method Tolerability of Genistein Treatment 6 months To assess the tolerability of genistein as an anti-obesity treatment in children aged 4-18 years with obesity, as measured by the incidence of adverse events, treatment discontinuation rates, and tolerability questionnaires completed by caregivers and participants (e.g., Likert scale or standardized adverse event checklist).
Adherence to Genistein Treatment 6 months To assess adherence to genistein as an anti-obesity treatment in children aged 4-18 years with obesity, as measured by the percentage of prescribed doses taken, recorded through pill counts, caregiver-reported adherence logs, and/or electronic medication monitoring (e.g., MEMS caps).