Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT06107192
Eligibility Criteria:
Inclusion Criteria:
1. Completion of informed consent.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Any gender identification, aged 18 - 45.
4. BMI 18.5 - 40 kg/m\^2
5. Ability to consume the intervention foods and beverages and be willing to adhere to the dietary regimen.
6. Agreement to provide urine and fecal samples according to the study protocol.
7. Agreement to adhere to avoid high catechin foods (tea, chocolate) for 4 weeks.
8. Able to come to the study location for 8 visits according to the study schedule.
9. As assessed through an initial urine screening phase, a person is eligible either on the basis of (1) the presence of a urinary marker for soy isoflavone metabolism (ODMA), or (2) as a control matched for age and gender.
Exclusion Criteria:
1. Current, regular use of antacids or acid reducers.
2. Systemic antibiotic use within the past month prior to the urinary screening until completion of the dietary intervention.
3. Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) at screening or planning to become pregnant during the study duration.
4. Known allergic reactions to components of the foods or beverages of the study diet (soy, wheat, dairy, peanut, tree nuts, apples, eggs) or any history of anaphylactic food allergy.
5. Current diagnosis of renal, hepatic, or gastrointestinal conditions.
6. History of stroke.
7. Underweight (BMI \<18.5 kg/m\^2) or severe obesity (BMI \>40 kg/m\^2).
8. Under 18 years or above 45 years of age.
9. Unwilling or unable to participate in the controlled dietary intervention or provide urine or fecal samples.
10. Has a pacemaker, implanted defibrillator, or other implanted electronic device.
11. Change of body weight \>10% between screening and dietary intervention.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06107192
Study Brief:
Protocol Section:
NCT06107192