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Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Cardiovascular Diseases in Old Age

Treatments

Dietary Supplement: BRJ Placebo
Dietary Supplement: BRJ Nitrate

Study type

Interventional

Funder types

Other

Identifiers

NCT05380167
IRB000022922

Details and patient eligibility

About

The objective of this study was to determine the chronic effects of beetroot juice supplementation on the acute (90-minute post nitrate consumption) efficacy of converting dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults. the investigators were also interested in determining the effect of this intervention on fasting levels of plasma nitrate and nitrite over time. Furthermore, the number of participants classified as "non-responders" was determined based on increases in plasma nitrite achieved using tolerable volumes of beetroot juice by other studies.

Enrollment

13 patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Middle and Older (40-80 year-old) men and women
  • Body mass index between 18.5 - 30.0 kg/m2
  • Able to provide own transportation to study testing visits
  • Able to consume study beverages
  • Able to speak and read English

Exclusion criteria

  • Tobacco user (smoke or chew), including e-cigarettes
  • Known conditions of: diabetes mellitus (type 1 or 2), atrophic gastritis, hypo- or hyperthyroidism, gout, history of kidney stones, history of hypotension, cardiovascular disease, chronic obstructive pulmonary disease, inflammatory bowel diseases, impaired liver or kidney function
  • Current or recent (last 3 months) treatment for cancer
  • Current use of the following medications: Phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, medication for hypothyroidism, antacid and heartburn medications

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

13 participants in 2 patient groups, including a placebo group

BRJ Nitrate
Experimental group
Description:
This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate.
Treatment:
Dietary Supplement: BRJ Nitrate
BRJ Placebo
Placebo Comparator group
Description:
This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate.
Treatment:
Dietary Supplement: BRJ Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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