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Completed

NCT Number: NCT05380167

Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

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.

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Key information

Conditions

Cardiovascular Diseases in Old Age

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

BRJ Nitrate

Dietary Supplement

Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate.

BRJ Placebo

Dietary Supplement

Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate

Primary outcomes

  1. Fasting Plasma Nitrate

    Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12

    Concentration of nitrate in the plasma obtained at the start of each testing visit

  2. Fasting Plasma Nitrite

    Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12

    Concentration of nitrite in the plasma obtained at the start of each testing visit

  3. 90 minute plasma Nitrate

    Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12

    Concentration of nitrate in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage

  4. 90 minute plasma Nitrite

    Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12

    Concentration of nitrite in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

Efficacy and Variability in Plasma Nitrite Levels During Long-term Supplementation With Nitrate Containing Beetroot Juice

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2022
Registry last updated
May 25, 2022

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.

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