Last updated: February 26, 2024
Sponsor: University of Iowa
Overall Status: Completed
Phase
N/A
Condition
Aging
Atherosclerosis
Treatment
Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)
Clinical Study ID
NCT06071728
202204445
Ages 60-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 60-85 years
- Able to undergo cardiovascular testing procedures including fasting overnight andholding selected morning medication doses.
- Ability to understand and willingness to sign a written informed consent document.
- Ability to lie comfortably for up to 90 minutes
- Women only: Post-menopausal
Exclusion
Exclusion Criteria:
- Current or history of CVD disease (heart attack, stroke, heart failure, cardiomyopathyor peripheral artery disease, heart angioplasty/stent or bypass surgery, valvereplacement, carotid endarterectomy, heart transplant.
- Medical history of stroke or other neurological disorder or systemic illness thatcould potentially affect cognition or brain function (outside of a diagnosis of MCI,Alzheimer's Disease) or could affect their safety or comfort while undergoing theimaging or cardiovascular studies.
- Subjects with evidence of cardiovascular disease at baseline or during the exercisetest (evidence of myocardial infarction, abnormal cardiac arrhythmia, myocardialischemia, conduction delays, >1mm ST segment depression or elevation; >3 beatventricular tachycardia; atrial fibrillation) will be excluded from the study.
- Wilson's disease, hemochromatosis
- Individuals taking clonidine or other short-acting beta blocker
- Resting blood pressure > 149 mmHg systolic and/or 99mmHg diastolic
- BMI > 40 kg/m2
- Medical history of chronic major psychiatric or current diagnosis of major psychiatricdisease (other than dementia).
- Unable to provide informed consent due to cognitive impairment
- Current clinically abnormal thyroid function not adequately regulated by thyroidhormone supplementation or medication.
- Allergic to olives, artichokes, grapes or melons
- Current tobacco user or history of tobacco use within the past 3 months (cigarettes,cigars, chewing tobacco, hookah, electronic cigarettes) or living with someone whosmokes/has smoked in the past 3 months.
- Current diagnosis of diabetes (Type I or insulin dependent Type II)
- Current diagnosis of COPD, cystic fibrosis, emphysema, chronic bronchitis
- History of renal failure, dialysis or kidney transplant
- Current diagnosis or history of liver disease or HIV/AIDS, or cancer requiringchemotherapy or radiation.
- Current diagnosis or history of rheumatoid arthritis, systemic lupus erythematosus,Wegener's granuomatosis
- Vulnerable populations (prisoners, etc) will not be eligible.
- Unwillingness to wash out from a vitamin or dietary supplement regime prior toenrollment and maintain throughout the duration of the study.
- Inability to comply with experimental instructions.
- Uncontrolled intercurrent illness that would limit compliance with study requirementsper investigator.
- Inability to fast or hold morning medications doses until after testing is complete.
- Hormone replacement use within the past 6 months
- Currently enrolled in another study using an study medication, supplement, device orintervention.
- Initiation of a new prescription medication or change in dose/frequency in the pastthree months. Individuals will be become eligible after the medication/dose/frequencyhas been stable for 3 months.
Study Design
Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)
Phase:
Study Start date:
October 10, 2022
Estimated Completion Date:
January 31, 2024
Connect with a study center
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available

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