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 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT02379403
Eligibility Criteria:
* INCLUSION CRITERIA:
An Associate Investigator will examine participants and determine their eligibility according to the inclusion and exclusion criteria as documented by the eligibility checklist.
* Men and women between the ages 55-70 years
* In good general health as determined by physical exam and normal ranges obtained during screening
* Post-menopausal women (no menses within 12 months)
* Normal or pre-hypertensive blood pressure (e.g., SBP less than or equal to 139 mmHg and DBP less than or equal to 89 mmHg)
* Normal or mild hyperlipidemia (e.g., TC less than or equal to 239, LDL less than or equal to159, Triglycerides less than or equal to 199, HDL \<45 mg/dL)
* BMI between 18.5 to 25kg/m2
* Willing and ability to sign consent
* Willing to make time commitment for study
* Individuals who are fluent in English
EXCLUSION CRITERIA:
* Progressive or unstable known disease of any body system including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal, or immunologic disorders
* Known acute and chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematous, hepatitis)
* Elevated C-reactive protein level (\>3.0mg/L)
* Current (or within the last 3 months) smoking of any tobacco products, i.e., cigarettes, pipe
* Abnormal Complete Metabolic Panel (CMP), Complete Blood Count (CBC), cholesterol panel, Thyroid Stimulating Hormone (TSH), Erythrocyte Sedimentation Rate (ESR) -- (laboratory values outside of acceptable reference range for older adults if determined to
be clinically significant)
* Indications of current or within last 3 years substance or alcohol abuse
* Alcohol consumption \>1 drink/day, i.e., 1 bottle of beer, half glass of wine, 1 shot hard liquor
* Known sensitivity or allergy to tart cherry or aroniaberry
* Currently on cholesterol-lowering, anti-hypertensive, thyroid, steroid or hormonal medications
* Routine use of vitamins, supplements, or over the counter medications including aspirin, aspirin-containing products, non-steroidal anti-inflammatory drugs (NSAIDs), i.e., motrin, advil, aleve, unless they were discontinued 14 days prior to their first visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT02379403
Study Brief:
Protocol Section:
NCT02379403