Skip to main content
OpenTrials
Completed

NCT Number: NCT04283630

Nitrate and Vitamin C on Vascular Health Oxidative Stress

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky, Lexington, Kentucky, United States

Loading trial locations.

About this study

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 and nitrite), and plasma vitamin C, plasma oxidized LDL, and blood (secondary outcome) following treatment with inorganic nitrate and vitamin C placebo (N) and inorganic nitrate combined with vitamin C (NC). Following baseline testing, eligible subjects were randomized to receive either treatment (N) or treatment (NC) for 4 weeks (period1), and participants were then crossed over to the alternate treatment for another 4 weeks (period 2). There was a 2-week washout at crossover.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Dietary nitrate in the form of beetroot juice for all participnats

Dietary Supplement

participants asked to consume dietary nitrate in the form of beet juice everyday in the morning and then one hour later, the vitamin C capsules.

Other names: Sport Beet IT shot

Nature Made vitamin c 1000 mg

Dietary Supplement

vitamin C and the placebo were provided as supplement capsules. Participants were asked to consume one dose/shot of sport Beet IT (70ml) that delivers on average 300-400mg of inorganic nitrate every day in the morning during the four-week study period, except for the test days and washout weeks. Accordingly, the participant were asked to consume the daily vitamin C supplement (1000 mg) or placebo one-hour post beetroot juice supplementation.

Placebo

Dietary Supplement

Vitamin C matched Placebo capsules that made from starch.

Primary outcomes

  1. Change of peripheral endothelial function

    Time frame: Change from baseline endothelial function at 4 weeks of each treatment intervention period

    Non-invasive technique called peripheral artery tonometry reactive hyperemia (PAT-RH)

Secondary outcomes

  1. Change of plasma total nitric oxide (NOx)

    Time frame: Change from baseline plasma NOx at 4 weeks of each treatment intervention period

    Sum of nitric oxide metabolites (nitrite and nitrate) were assessed

  2. Change of blood biomarker of oxidative stress

    Time frame: Change from baseline oxLDL at 4 weeks of each treatment intervention period

    Oxidized low density lipoprotein (oxLDL)

  3. Change of blood lipids

    Time frame: Change from baseline blood lipids at 4 weeks of each treatment intervention period

    Total cholesterol(TC), low density lipoprotein(LDL), triglycerides(TG), and high density lipoprotein (HDL)

Sponsors and collaborators

Lead sponsor

David Travis Thomas

Other

Registry information

Official study title

The Combined Effect of Dietary Nitrate and Vitamin C on Endothelial Function, Oxidative Stress Biomarkers, and Blood Lipids

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2020
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.