Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion

Cardiovascular Diseases in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380167
• Other study ID #: IRB000022922
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2022
• Source: Wake Forest University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Diseases in Old Age

Intervention

Dietary Supplement:
• BRJ Nitrate
Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate.
• BRJ Placebo
Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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