Nitrate and Vitamin C on Vascular Health Oxidative Stress

NCT04283630 | Completed

• 1 other identifier: 17-0412-F3R
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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

Conditions

Endothelial Dysfunction

Keywords

Nitrate; Vitamin C; Endothelial function; Nitric Oxide

Outcome Measures

Primary Outcomes (1)

• Change of peripheral endothelial function

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

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

Secondary Outcomes (3)

• Change of plasma total nitric oxide (NOx)

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

• Change of blood biomarker of oxidative stress

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

• Change of blood lipids

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

Study Arms (2)

Randomization and Dietary supplement Interventions

ACTIVE COMPARATOR

The dietary nitrate supplement was provided in the form of commercial beetroot juice (Sport Beet IT shot, Heartbeet Ltd) for all participants, whereas 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 concentrated beetroot juice with breakfast meals, and then the vitamin C supplement (1000 mg)or placebo at the same time one-hour post beetroot juice supplementation

Dietary Supplement: Dietary nitrate in the form of beetroot juice for all participnats; Dietary Supplement: Nature Made vitamin c 1000 mg

Placebo

PLACEBO COMPARATOR

Vitamin C placebo was matched with the active vitamin c capsules in shape, color, and size.

Dietary Supplement: Dietary nitrate in the form of beetroot juice for all participnats; Dietary Supplement: Placebo

Interventions

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.

Also known as: Sport Beet IT shot

Placebo; Randomization and Dietary supplement Interventions

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.

Randomization and Dietary supplement Interventions

Placebo DIETARY_SUPPLEMENT

Vitamin C matched Placebo capsules that made from starch.

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• David Travis Thomas: lead

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40514, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• Basaqr R, Skleres M, Jayswal R, Thomas DT. The effect of dietary nitrate and vitamin C on endothelial function, oxidative stress and blood lipids in untreated hypercholesterolemic subjects: A randomized double-blind crossover study. Clin Nutr. 2021 Apr;40(4):1851-1860. doi: 10.1016/j.clnu.2020.10.012. Epub 2020 Oct 14.

  PMID: 33115598 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Crossover double blinded crossover study

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 25, 2020
• Study Start: February 5, 2018
• Primary Completion: September 15, 2019
• Study Completion: December 13, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)