Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

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.

Official Title
-----------------
Efficacy and Variability in Plasma Nitrite Levels During Long-term Supplementation With Nitrate Containing Beetroot Juice

Conditions
-----------------
Cardiovascular Diseases in Old Age

Intervention / Treatment
-----------------
* Dietary Supplement: BRJ Nitrate
* Dietary Supplement: BRJ Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRJ Nitrate<br>This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate. | Dietary Supplement: BRJ Nitrate<br>* Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate.<br>|
| Placebo Comparator: BRJ Placebo<br>This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate. | Dietary Supplement: BRJ Placebo<br>* Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
beetroot juice, dietary nitrate, plasma nitrite