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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT06476795
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal female, with a cessation of menses for at least 2 years
* 45-70 years of age
* BMI 25- 49.9 kg/m2
* Fasting triglycerides \> 120 mg/dL
* Subject is willing and able to comply with the study protocols and procedures.
Exclusion Criteria:
* Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
* Prescription medications and supplements, except for a 6 month stable dose of thyroid medications
* Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
* Fruit consumption ≥ 3 cups/day
* Vegetable consumption ≥ 4 cups/day
* Coffee/tea ≥ 3 cups/day
* Dark chocolate ≥ 3 oz/day
* Self-reported restriction of physical activity due to a chronic health condition
* Self-reported chronic/routine high intensity exercise
* Blood pressure ≥ 140/90 mm Hg
* Self-reported renal or liver disease
* Self-reported heart disease, which includes cardiovascular events and stroke, diabetes
* Peripheral artery disease Raynaud's syndrome or disease
* Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
* Self-reported cancer within past 5 years
* Self-reported gastrointestinal disorders, apart from appendix removal
* Unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements six weeks prior to study enrollment.
* Indications of substance or alcohol abuse within the last 3 years
* All forms of smoking (e.g. vaping, cigarette, cannabis)
* Current enrollee in a clinical research study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT06476795
Study Brief:
Protocol Section:
NCT06476795