NCT07033767Toborzás még nem indult1/2. fázis
Exploring a Natural Solution for Childhood Obesity
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 24. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2025. jún. 10.
- Kezdés
- 2025. aug. 1.
- Elsődleges befejezés
- 2026. aug. 1.
- Fő szponzor
- Western University
- Betegségek
- Elhízás
- NCT-szám
- NCT07033767
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 30
- 2025. aug. 1. és az elsődleges befejezés (2026. aug. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Ki nem vehet részt
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Korábbi kezelés
- Current use of medications that may confound study outcomes, including:
- ADHD medications (e.g., Concerta, Vyvanse, Abilify)
- Antipsychotic medications (e.g., Risperidone)
Más betegség
- Known allergy to Sophora japonica (source of genistein).
- Diagnosis of type 2 diabetes (these patients are followed in a separate Diabetes Clinic).
Egyéb
- GLP-1 receptor agonists (e.g., Saxenda, Wegovy)
- Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 4 év – 17 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.