Exploring a Natural Solution for Childhood Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: genistein.
- Who it may be relevant to
- Registry conditions: Obesity, Children. Basic parameters: 4 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 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 c
Primary outcome measures
- Change in Body Mass Index (BMI) z-score [Time frame: 6 months]
Secondary outcome measures (2)
- Tolerability of Genistein Treatment [Time frame: 6 months]
- Adherence to Genistein Treatment [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07033767 · 125367