Clinical trial NCT04125940: Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women
Official title: Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Resync
Nitrate
Nitrite
Healthy
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Resync, LLC
First posted: 2019-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blind, pre-post ingestion, control
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates acute ingestion of the dietary supplement Resync on blood nitrate/nitrite concentrations in a sample of men and women. This will be a crossover trial in which participants take all 4 conditions: 1) 7.5g Resync, 2) 15g Resync, 3) 20g Resync+collagen, 4) placebo.

Detailed description: The product known as Resync contains a blend of nitrate-rich foods including beetroot, red spinach, turmeric, ginger root, and aronia berry extracts. Resync is sold commercially and marketed as an ergogenic aid and/or exercise recovery aid. Manufacturers of Resync recommend users take this product 60-90 minutes before an athletic event or 30-90 minutes after exercise. Resync bases these claims on prior studies investigating the individual ingredients' abilities to increase blood nitrate/nitrite levels; however, there are no clinical trials on the finished product itself.

The purpose of this pilot study is to determine the impact of acute, single ingestion of Resync products on blood nitrate/nitrite concentration in a sample of men and women. This will be a crossover trial in which participants take all 4 conditions: 1) 7.5g Resync, 2) 15g Resync, 3) 20g Resync+collagen, 4) placebo.

Eligibility criteria: Inclusion Criteria:

* BMI 18 - 29.9 kg/m2
* Non-smoker
* Non-vegan
* Not using nitrate-based dietary supplements

Exclusion Criteria:

* Diagnosed history of diabetes
* Diagnosed history of cardiovascular disease
* Diagnosed history of neurological disease
* Pregnant females

Primary outcomes:
measure: Change in blood nitrate+nitrite levels from daily baseline with 7.5g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in blood nitrate+nitrite levels from daily baseline with 15g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in blood nitrate+nitrite levels from daily baseline with 20g Resync+Collagen
timeFrame: 75-minutes post supplement ingestion
measure: Change in blood nitrate+nitrite levels from daily baseline with placebo.
timeFrame: 75-minutes post supplement ingestion
measure: Change in systolic blood pressure from daily baseline with 7.5g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in systolic blood pressure from daily baseline with 15g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in systolic blood pressure from daily baseline with 20g Resync+Collagen
timeFrame: 75-minutes post supplement ingestion
measure: Change in systolic blood pressure from daily baseline with placebo
timeFrame: 75-minutes post supplement ingestion
measure: Change in diastolic blood pressure from daily baseline with 7.5g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in diastolic blood pressure from daily baseline with 15g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in diastolic blood pressure from daily baseline with 20g Resync+Collagen
timeFrame: 75-minutes post supplement ingestion
measure: Change in diastolic blood pressure from daily baseline with placebo
timeFrame: 75-minutes post supplement ingestion
Secondary outcomes:
measure: Change in heart rate from daily baseline with 7.5g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in heart rate from daily baseline with 15g Resync
timeFrame: 75-minutes post supplement ingestion
measure: Change in heart rate from daily baseline with placebo
timeFrame: 75-minutes post supplement ingestion
measure: Change in heart rate from daily baseline with 20g Resync+Collagen
timeFrame: 75-minutes post supplement ingestion
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: Dean of School of Health Studies
name: Richard J Bloomer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: