Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

Not Applicable

Completed

• Conditions: Cardiovascular Diseases in Old Age
• Interventions: Dietary Supplement: BRJ Placebo; Dietary Supplement: BRJ Nitrate

• Registration Number: NCT05380167
• Lead Sponsor: Wake Forest University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRJ Placebo	BRJ Placebo	This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate.
BRJ Nitrate	BRJ Nitrate	This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate.

Primary Outcome Measures

Name	Time	Method
90 minute plasma Nitrite	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
Fasting Plasma Nitrate	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
Fasting Plasma Nitrite	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
90 minute plasma Nitrate	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

Trial Locations

Locations (1)

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States