Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

Wake Forest University13 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Cardiovascular Diseases in Old Age

Interventions

BRJ NitrateDIETARY_SUPPLEMENT

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

BRJ PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Fasting Plasma Nitrate

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

Time frame: 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

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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