Exploring a Natural Solution for Childhood Obesity

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Change in Body Mass Index (BMI) z-score [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Tolerability of Genistein Treatment [Срок оценки: 6 months]
• Adherence to Genistein Treatment [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07033767 · 125367

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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