Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases in Old Age
• Intervention / Treatment: Dietary supplement: BRJ Nitrate; Dietary supplement: BRJ Placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRJ Nitrate; This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate.	Dietary supplement: BRJ Nitrate; Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate.
Placebo Comparator: BRJ Placebo; This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate.	Dietary supplement: BRJ Placebo; Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Plasma Nitrate	Concentration of nitrate in the plasma obtained at the start of each testing visit	Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Fasting Plasma Nitrite	Concentration of nitrite in the plasma obtained at the start of each testing visit	Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
90 minute plasma Nitrate	Concentration of nitrate in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage	Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
90 minute plasma Nitrite	Concentration of nitrite in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage	Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12

Collaborators and Investigators

• Sponsor: Wake Forest University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: dietary nitrate; beetroot juice; plasma nitrite
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB000022922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No