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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT01382056
Eligibility Criteria:
Inclusion Criteria:
Healthy Participants, Acute Phase:
* Healthy volunteers, male or female, \>33 years of age, age matched with PAD participants ± 7 years;
* BMI 18-30;
* Glycated hemoglobin \< 6.5%;
* Fasting serum total cholesterol \< 4 mmol/L and triglycerides \< 2.5 mmol/L;
* Blood pressure \< 140/90 mm Hg;
* Ankle-brachial Index (ABI) \>0.9;
* Willing to comply with the protocol requirements;
* Willing to provide informed consent.
Inclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):
* Male or female, \> 40 years of age;
* Documented Peripheral Artery Disease including those with claudication as defined by an ankle brachial Index of ≤ 0.90; or asymptomatic carotid stenosis of \> 50% or confirmed by imaging; or having had a previous intervention for Peripheral Artery Disease or carotid disease;
* Stable medication profile with no changes required for the past 3 months;
* Willing to comply with the protocol requirements;
* Willing to provide informed consent.
Exclusion Criteria:
Healthy Participants, Acute Phase:
* Currently smoking, or smoking within the last 6 months;
* Clinically diagnosed disease affecting the heart, liver, kidneys, lungs, gastrointestinal, endocrine or blood/immune systems that requires medical treatment;
* Taking any prescribed medication with the exception of birth control and hormone (estrogen) replacement therapy;
* Pregnancy;
* Amputation of upper or lower extremity on both sides;
* History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods.
Exclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):
* Currently smoking, or smoking within the last 6 months;
* Type 1 diabetes;
* Renal failure requiring dialysis;
* Acute cardiovascular event or medical illness within the past 3 months precluding study participation;
* Hormone (estrogen) replacement therapy;
* Amputation of upper or lower extremity on both sides;
* History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods;
* Currently participating in or having participated in a food study within the last 3 months unless randomized to a control group and consumed no study foods;
* High pulse consumption (greater or equal to 2 servings per week);
* Inability to adhere to a regular diet;
* Additional intake of pulses other than the requirements outlined in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
34 Years
Study:
NCT01382056
Study Brief:
Protocol Section:
NCT01382056