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:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT05400005
Eligibility Criteria:
Inclusion Criteria:
1. Adults 60-85 years old
2. Not following HPB diet
Exclusion Criteria:
1. Weight change \> 3kg in the past 3 months
2. Exercise vigorously over the past 3 months
3. Drinking more than 2 alcoholic drinks per day
4. (if applicable) Pre-menopausal women
5. Taking dietary supplements or medications which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), Trp, 5-HTP or melatonin supplementations) the past 1 month
6. Taking dietary supplements which may impact the gut microbiota (e.g. antibiotics, prebiotics, probiotics) the past 2 months (a list of fermented foods)
7. Impaired renal function (normal values: estimated glomerular filtration rate ≥ 90 mL/min/1.73 m2 calculated by chronic kidney disease epidemiology collaboration equation; CKD EPI)
8. Soy intolerance and/or allergy or any medical conditions that may be affected by consumption of soy products (e.g. gout)
9. Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication or Chinese medicine herb which started less than 3 years prior to the intervention participation
10. Diagnosed with gut/gastrointestinal issues such as lactose intolerance and irritable bowel syndrome (IBS)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT05400005
Study Brief:
Protocol Section:
NCT05400005