Nitrate and Vitamin C on Vascular Health Oxidative Stress

Completed · Not applicable · Has a placebo group

Conditions studied: Endothelial Dysfunction

In brief

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 function using blood measures and a non-invasive technique (Peripheral Artery Tonometry) compared to dietary nitrate supplementation alone.

Key facts

Study ID

NCT04283630

Run by

David Travis Thomas

People needed

23

Starts

2018-02-05

Expected to finish

2019-12-13

Last updated by the study team

2020-02-25

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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