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Clinical Trials/NCT04125940
NCT04125940CompletedNot Applicable

Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women

University of Memphis1 site in 1 country20 target enrollmentStarted: October 14, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change in systolic blood pressure from daily baseline with 15g Resync

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Masking Description

Single-Blind

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Placebo-controlled Arm

Placebo Comparator

Placebo - 12oz water with food coloring

Intervention: Placebo (Other)

1 serving Resync Arm

Active Comparator

12oz water + 7.5g Resync

Intervention: Resync (Dietary Supplement)

2 servings Resync Arm

Active Comparator

12oz water + 15g Resync

Intervention: Resync (Dietary Supplement)

1 servings Resync+Collagen Arm

Active Comparator

12oz water + 17g collagen + 2g Resync + 1g Carbohydrates

Intervention: Resync + Collagen (Dietary Supplement)

Outcomes

Primary Outcomes

Change in systolic blood pressure from daily baseline with 15g Resync

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily systolic blood pressure with supplementation from the daily baseline systolic blood pressure with 2 servings (15g) of Resync. Resync powder will be mixed with 12oz of water.

Change in systolic blood pressure from daily baseline with 20g Resync+Collagen

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily systolic blood pressure with supplementation from the daily baseline systolic blood pressure with 1 serving (20g) of Resync+Collagen. This blend contains approximately 17g of collagen, 2 g of Resync, and 1g carbohydrates. Resync+Collagen powder will be mixed with 12oz of water.

Change in blood nitrate+nitrite levels from daily baseline with 7.5g Resync

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily blood nitrate+nitrite from the daily baseline blood nitrate+nitrite with 1 serving (7.5g) of Resync. Resync powder will be mixed with 12oz of water.

Change in blood nitrate+nitrite levels from daily baseline with 15g Resync

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily blood nitrate+nitrite from the daily baseline blood nitrate+nitrite with 2 servings (15g) of Resync. Resync powder will be mixed with 12oz of water.

Change in blood nitrate+nitrite levels from daily baseline with 20g Resync+Collagen

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily blood nitrate+nitrite from the daily baseline blood nitrate+nitrite with 1 serving (20g) of Resync+Collagen. This blend contains approximately 17g of collagen, 2 g of Resync, and 1g carbohydrates. Resync+Collagen powder will be mixed with 12oz of water.

Change in blood nitrate+nitrite levels from daily baseline with placebo.

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily blood nitrate+nitrite from the daily baseline blood nitrate+nitrite with 12oz of food colored water. A red food dye will be used to match coloring of supplements.

Change in systolic blood pressure from daily baseline with 7.5g Resync

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily systolic blood pressure with supplementation from the daily baseline systolic blood pressure with 1 serving (7.5g) of Resync. Resync powder will be mixed with 12oz of water.

Change in diastolic blood pressure from daily baseline with 15g Resync

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily diastolic blood pressure with supplementation from the daily baseline diastolic blood pressure with 2 servings (15g) of Resync. Resync powder will be mixed with 12oz of water.

Change in diastolic blood pressure from daily baseline with 7.5g Resync

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily diastolic blood pressure with supplementation from the daily baseline diastolic blood pressure with 1 serving (7.5g) of Resync. Resync powder will be mixed with 12oz of water.

Change in systolic blood pressure from daily baseline with placebo

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily systolic blood pressure with supplementation from the daily baseline systolic blood pressure with 12oz of food colored water. A red food dye will be used to match coloring of supplements.

Change in diastolic blood pressure from daily baseline with placebo

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily diastolic blood pressure with supplementation from the daily baseline diastolic blood pressure with 12oz of food colored water. A red food dye will be used to match coloring of supplements.

Change in diastolic blood pressure from daily baseline with 20g Resync+Collagen

Time Frame: 75-minutes post supplement ingestion

We will determine the change in daily diastolic blood pressure with supplementation from the daily baseline diastolic blood pressure with 1 serving (20g) of Resync+Collagen. This blend contains approximately 17g of collagen, 2 g of Resync, and 1g carbohydrates. Resync+Collagen powder will be mixed with 12oz of water.

Secondary Outcomes

  • Change in heart rate from daily baseline with 15g Resync(75-minutes post supplement ingestion)
  • Change in heart rate from daily baseline with placebo(75-minutes post supplement ingestion)
  • Change in heart rate from daily baseline with 7.5g Resync(75-minutes post supplement ingestion)
  • Change in heart rate from daily baseline with 20g Resync+Collagen(75-minutes post supplement ingestion)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Richard Bloomer

Dean of School of Health Studies

University of Memphis

Study Sites (1)

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