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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT00955903
Eligibility Criteria:
Inclusion Criteria:
* at least 65 years of age
* BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)
Exclusion Criteria:
* difficulties chewing or swallowing food
* digestive diseases that may affect the ability to follow a high fiber diet
* cognitive impairment
* depression
* recent weight change (+/- 10 lbs in the last 12 months)
* poorly controlled blood pressure
* history of non-skin cancer in last 5 years
* cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure
* major liver dysfunction
* current smoker or quit less than months prior
* history of prior surgical procedures for weight control or liposuction
* use of estrogen or testosterone replacement therapy
* current use of insulin or sulfonylurea agents
* current use of corticosteroids \> 5 days/month on average
* current use of medications for treatment of psychosis or manic-depressive illness
* use of weight-loss medications in previous 3 months
* dependence on others for food procurement or preparation
* ischemic changes on exercise treadmill test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00955903
Study Brief:
Protocol Section:
NCT00955903