ObesityPhase 1/2NCT07033767
Exploring a Natural Solution for Childhood Obesity
A Phase 1/2 study testing genistein in people with Obesity and Children, run by Western University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- What is being tested?
- genistein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Being tested
- genistein
- Keywords
- genistein, childhood obesity, children
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genisteinDrug
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 clinical evaluations will occur at 3 and 6 months to assess, tolerability, adherence and efficacy.. Post-treatment assessment after a 3-month washout will occur at 9 months to determine delayed adverse effects and persistence of beneficial effects after genistein discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Other | 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) Receives: Drug: genistein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI) z-score
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.
Measured: 6 months
Secondary outcomes (2)
Tolerability of Genistein Treatment
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).
Measured: 6 months
Adherence to Genistein Treatment
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Principal investigator, Marina Ybarra, Western University
- Investigators
- Marina Ybarra, MD, MSc, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033767
- Sponsor's protocol ID
- 125367
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single center study with only one primary investigator
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring a Natural Solution for Childhood Obesity
- ClinicalTrials.gov ID
- NCT07033767
- Acronym / sponsor ID
- 125367
- Keywords
- genistein, childhood obesity, children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western UniversityUniversity, hospital or other
- Collaborators
- Western University, Canada, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Other | Drug: genisteinArm 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) |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genisteinParticipants 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 clinical evaluations will occur at 3 and 6 months to assess, tolerability, adherence and efficacy.. Post-treatment assessment after a 3-month washout will occur at 9 months to determine delayed adverse effects and persistence of beneficial effects after genistein discontinuation. | Drug | single arm study |
Primary outcome
Change in Body Mass Index (BMI) z-score
Time frame: 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.
2 secondary outcomes
Tolerability of Genistein Treatment
Time frame: 6 months
Adherence to Genistein Treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. This is a single center study with only one primary investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina Ybarra, MD, MSc principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing genistein in people with Obesity and Children, run by Western University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Ybarra, MD, MSc (+15196858500 ext. 75751, marina.ybarra@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) z-score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.