Efficacy and Variability in Plasma Nitrite Levels During Long-term Supplementation With Nitrate Containing Beetroot Juice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wake Forest University
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- 90 minute plasma Nitrite
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
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
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Gary Miller
Professor
Wake Forest University