Status:
COMPLETED
Nitrate and Vitamin C on Vascular Health Oxidative Stress
Lead Sponsor:
David Travis Thomas
Conditions:
Endothelial Dysfunction
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
The objective of this study is to examine whether the co-administration of dietary nitrate combined with vitamin C for 4 weeks in patients at risk for CVD would yield robust effects on endothelial fun...
Detailed Description
This is a 10 week randomized, cross-over, double-blinded, placebo-controlled study. This study was designed to compare the magnitude changes in RHI (primary outcome), plasma NO metabolites (nitrate an...
Eligibility Criteria
Inclusion
- Age: between 50 and 70 years
- Body mass index (BMI) of 18.5-34.9 kg/m2
- Reactive hyperemia index (RHI) of \< or equal to 2
- High cholesterol levels with LDL concentrations (\>130 mg/dL)
- Not receiving any lipid lowering therapy.
- Non-smokers
Exclusion
- Evidence of overt atherosclerotic disease (i.e., documented medical history of coronary artery disease, peripheral artery disease, cardiovascular disease, and stroke).
- Any surgery or medical history that could confound study results, such as a history of bowel resection, rheumatoid arthritis, inflammatory bowel disease, celiac disease, diabetes, uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg), controlled hypertension on clonidine medication.
- Participants were ineligible if they had been diagnosed with the following medical conditions such as active cancer, severe anemia (Hb \< 10mg/dL), hepatic or renal disease, heart failure, or finger deformities.
- HIV-positive patients on combination antiretroviral therapy because of potential pharmacokinetic interactions with beetroot juice were excluded.
- Participants were also excluded if they reported taking any form of hormone replacement therapy (estrogens, progesterone, and testosterone), multivitamin supplements that provides \>100% of RDA, or any of the following medications that attenuate nitrate conversion to NO: proton pump inhibitors (PPI) and antibiotics.
- Participants who consumed greater than 6 drinks of alcohol (any form) per week, performed structured resistance or aerobic training for more than 1-hour four times per week, or participated in other clinical intervention within the previous 30 days were excluded from the study.
- Eligible subjects were asked to avoid using the mouthwash before and throughout the study duration. In addition, enrolled participants were advised to consume low- vitamin c diet throughout the study. They were provided at the beginning of the study with a list of high vitamin C foods/fortified foods to avoid during the study.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04283630
Start Date
February 5 2018
End Date
December 13 2019
Last Update
February 25 2020
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40514
2
University of Kentucky
Lexington, Kentucky, United States, 40536