Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

NCT05380167 | Completed

• 1 other identifier: IRB000022922
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases in Old Age

Keywords

beetroot juice; dietary nitrate; plasma nitrite

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

BRJ Nitrate

EXPERIMENTAL

This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate.

Dietary Supplement: BRJ Nitrate

BRJ Placebo

PLACEBO COMPARATOR

This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate.

Dietary Supplement: BRJ Placebo

Interventions

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 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

BRJ Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A third party not involved with the conduct of the study provided research staff with the beetroot juice in participant specific coded bottles. The research staff then distributed these coded bottles to the participant. At the end of the trial, the code was revealed for intervention assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: September 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)