Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Diseases in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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BRJ Nitrate

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

Group Type EXPERIMENTAL

BRJ Nitrate

Intervention Type DIETARY_SUPPLEMENT

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

BRJ Placebo

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

Group Type PLACEBO_COMPARATOR

BRJ Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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BRJ Nitrate

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

Intervention Type DIETARY_SUPPLEMENT

BRJ Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes