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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT05818358
Eligibility Criteria:
Inclusion Criteria:
1. Male, or non-pregnant, non-lactating female, 45 to 65 years of age;
2. Brachial-ankle pulse wave velocity \>1400 cm/s on at least one side;
3. Plasma creatinine ≤265 µmol/L;
4. Aspartate aminotransferase \<160 U/L, andalanine aminotransferase \<150 U/L;
5. Glycated hemoglobin ≤6.5%;
6. LDL-cholesterol \<5 mmol/L;
7. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
8. Has not donated blood or blood products (e.g. platelets) during the past 2 months and willing to continue doing so while participating in the study;
9. Not participating in another dietary intervention trial for the past month and willing to not start another dietary intervention trial for the duration of this study;
10. Willing to comply with the protocol requirements and procedures;
11. Willing to provide informed consent.
Exclusion Criteria:
1. Has experienced a cardiovascular event (e.g. heart attack, stroke) or had a surgical procedure for cardiovascular disease (e.g. bypass, stent), presence of clinically diagnosed cardiac arrhythmia or valve stenosis, chronic renal disease, liver disease (with exception of fatty liver), lung disease, rheumatoid arthritis, immune disorder or disease (e.g. multiple sclerosis, leukemia), cancer in the previous 5 years, neurological disorders, or gastrointestinal disorders;
2. Taking vasoactive medications (e.g., ACE inhibitors, ARBs, AGE-breakers, thiazolidinediones, beta-blockers, statins, insulin, etc.);
3. Blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic;
4. History of gastrointestinal reactions or allergies to beans, bean flour, wheat, wheat flour, gluten, or rice;
5. Body weight exceeds the capacity of the DEXA (350 lbs);
6. Current (within the past 30 days) bacterial, viral or fungal infection;
7. Bleeding disorder;
8. Amputations of upper or lower extremities on both sides;
9. Any acute medical condition or surgical intervention within the past 3 months;
10. Drug and/or alcohol abuse;
11. Psychological disorder(s);
12. Unable to fast overnight;
13. Unable to take prescribed medication without food;
14. Unable to obtain vascular function measurements and/or blood sample at the screening or first study visits;
15. Not fully vaccinated for COVID-19.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT05818358
Study Brief:
Protocol Section:
NCT05818358