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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT01495832
Eligibility Criteria:
Inclusion Criteria:
* Male or females, between 50-80 years of age
* Body Mass Index (BMI) of \>25 kg/m2
* Must be on a stable regime for the past 6 months if taking medications or supplements for elevated lipids, blood pressure, glucose management, mood, pain, or insomnia
* Consume 1 or less servings of pulses per week
* Able to read and understand English
* Willing to comply with the protocol requirements
* Willing to provide informed consent.
Exclusion Criteria:
* Body weight ≥135 kg (since this exceeds the capability for Dual Energy X-ray Absorptiometry, i.e, DEXA scanning to assess body composition)
* Established cardiovascular, liver, or kidney disease
* Uncontrolled diabetes (hemoglobin HbA1c \>8)
* A score of ≤23 on the Mini Mental State Examination
* Use of appetite suppressants or Orlistat (Xenical)
* Inability to consume pulse-enriched foods (i.e., beans, peas, chickpeas, and lentils) due to allergies or severe gastrointestinal reactions
* Pregnancy
* Smoking or only recently quit smoking (smoked any cigarettes within the last 12 months)
* Weight loss of ≥3kg of body weight within the 6 months prior to enrolling in the study
* Adherence to a weight loss diet or physical activity program designed to facilitate weight loss
* Acute or terminal illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT01495832
Study Brief:
Protocol Section:
NCT01495832