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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT02224092
Eligibility Criteria:
Inclusion Criteria:
* Generally healthy men and women aged from 40 to 70 years of age preferable smokers and who regularly consumes alcohol, and consuming fewer than 12 items found on the Recommended Foods Checklist (see below) per week.
* Individual should be judged to be in good general health on the basis of an interview and abbreviated physical exam.
* Individual understands the procedures and agrees to participate in the study.
* Individual is able and willing to provide written informed consent and confidentiality agreement.
Exclusion Criteria:
* Use of dietary supplements within one week of Day 1. Supplements include any vitamins, minerals, and herbal products, including herbal drinks.
* Presence of cardiovascular disease, hypercholesterolemia, cancer, diabetes mellitus, or any other chronic health condition identified from the findings of the interview.
* Currently treated for uncontrolled hypertension or blood pressure greater \> 140 mm Hg systolic or \> 90 mm Hg diastolic during seated, resting measurement on two consecutive occasions during visit 1.
* Therapeutic uses of coumadin, aspirin, or other medications that influence hemostasis within four weeks of Day 1.
* Participation in another clinical trial within 30 days of enrollment into the study.
* History or current abuse of drugs or alcohol, or intake \> 4 alcoholic beverages per day.
* Known hypersensitivity to study product or any ingredient in study product.
* A change in hormone therapy, including oral contraceptives, within 4 weeks prior to screening, or unwilling to maintain current hormone therapy/oral contraceptive use throughout the course of the study.
* Pregnant or lactating women, or women of child-bearing potential unwilling to use a medically approved form of birth control.
* Any condition that the Principal Investigator believes may put the subject at undue risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02224092
Study Brief:
Protocol Section:
NCT02224092