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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT00967733
Eligibility Criteria:
Inclusion Criteria:
* Age 50 or older at time of enrollment
* Willing to cook and eat foods prepared exclusively with the study oils and nothing else every day of the week at least 2 meals per day for 24 weeks
* Willing to eat no more than one meal per week prepared out of the home
* Willingness to take 4 or 8 capsules with ALA or placebo every day for 24 weeks
* Willingness to provide personal and next of kin address and phone number for follow-up visits to the home.
* Willingness to complete measurement procedures and blood draws.
* Ability and willingness to provide informed consent to be screened and to take part of the study.
Exclusion Criteria:
Medication Exclusions
• Unstable dose of medications during the past 2 months that raise or lower blood pressure, lipids or glucose. Unstable dose is a dose change in the past 6 months or less than 6 months of treatment.
Medical History Exclusions
* Active or prior CVD (stroke, MI, PTCA, CABG, congestive heart failure, symptomatic ischemic heart disease (angina), or CVD-related therapeutic procedure).
* Cancer diagnosis or treatment in past two years (however, persons with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy)
* Active inflammatory bowel disease, malabsorption, or major GI resection
* Chronic renal disease
* Any serious illness not otherwise specified that would interfere with participation
* Stage 2 hypertension (SBP \> 160 or DBP \> 100 mmHg) based on the mean of 3 measurements on the screening visit, as well as a systolic BP \> 170 or diastolic BP \> 105 at any of the measurements
Other Exclusions
* Eat fish more than once per week including canned fish
* Significant oil preferences, intolerances, dietary habits, or dietary requirements that would interfere with adherence
* Planning to leave the area for more than two weeks prior to the anticipated end of participation
* Current participation in another study that manipulates diet or that will affect the outcome of this study
* Taking vitamin, vegetable oil, fish-oil, weight-loss, soy, mineral, or herbal supplements that cannot be stopped
* Unable to measure blood pressure (due to arm circumference \> 50 cm)
* Investigator judgment (e.g. for concerns over adherence, or follow-up or for inappropriate behavior)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00967733
Study Brief:
Protocol Section:
NCT00967733