Exploring a Natural Solution for Childhood Obesity
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in Body Mass Index (BMI) z-score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
single arm study
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)
干预措施: genistein (Drug)
结局指标
主要结局
Change in Body Mass Index (BMI) z-score
时间窗: 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.
次要结局
- Tolerability of Genistein Treatment(6 months)
- Adherence to Genistein Treatment(6 months)
研究者
Marina Ybarra
MD, MSc - Assistant Professor
Western University