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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Resync; Dietary supplement: Resync + Collagen

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo-controlled Arm; Placebo - 12oz water with food coloring	Other: Placebo; 12oz water + food coloring
ACTIVE_COMPARATOR: 1 serving Resync Arm; 12oz water + 7.5g Resync	Dietary supplement: Resync; 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.
ACTIVE_COMPARATOR: 2 servings Resync Arm; 12oz water + 15g Resync	Dietary supplement: Resync; 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.
ACTIVE_COMPARATOR: 1 servings Resync+Collagen Arm; 12oz water + 17g collagen + 2g Resync + 1g Carbohydrates	Dietary supplement: Resync + Collagen; 17g Collagen + 2g Resync + 1g Carbohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood nitrate+nitrite levels from daily baseline with 7.5g Resync	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.	75-minutes post supplement ingestion
Change in blood nitrate+nitrite levels from daily baseline with 15g Resync	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.	75-minutes post supplement ingestion
Change in blood nitrate+nitrite levels from daily baseline with 20g Resync+Collagen	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.	75-minutes post supplement ingestion
Change in blood nitrate+nitrite levels from daily baseline with placebo.	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.	75-minutes post supplement ingestion
Change in systolic blood pressure from daily baseline with 7.5g Resync	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.	75-minutes post supplement ingestion
Change in systolic blood pressure from daily baseline with 15g Resync	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.	75-minutes post supplement ingestion
Change in systolic blood pressure from daily baseline with 20g Resync+Collagen	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.	75-minutes post supplement ingestion
Change in systolic blood pressure from daily baseline with placebo	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.	75-minutes post supplement ingestion
Change in diastolic blood pressure from daily baseline with 7.5g Resync	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.	75-minutes post supplement ingestion
Change in diastolic blood pressure from daily baseline with 15g Resync	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.	75-minutes post supplement ingestion
Change in diastolic blood pressure from daily baseline with 20g Resync+Collagen	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.	75-minutes post supplement ingestion
Change in diastolic blood pressure from daily baseline with placebo	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.	75-minutes post supplement ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate from daily baseline with 7.5g Resync	We will determine the change in daily heart rate with supplementation from the daily baseline heart rate with 1 serving (7.5g) of Resync. Resync powder will be mixed with 12oz of water.	75-minutes post supplement ingestion
Change in heart rate from daily baseline with 15g Resync	We will determine the change in daily heart rate with supplementation from the daily baseline heart rate with 2 servings (15g) of Resync. Resync powder will be mixed with 12oz of water.	75-minutes post supplement ingestion
Change in heart rate from daily baseline with placebo	We will determine the change in daily heart rate with supplementation from the daily baseline heart rate with 12oz of food colored water. A red food dye will be used to match coloring of supplements.	75-minutes post supplement ingestion
Change in heart rate from daily baseline with 20g Resync+Collagen	We will determine the change in daily heart rate with supplementation from the daily baseline heart rate 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.	75-minutes post supplement ingestion

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: Resync, LLC
• Investigators: Principal Investigator: Richard J Bloomer, Ph.D., Dean of School of Health Studies

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2019
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (ACTUAL): October 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Healthy; Nitrate; Nitrite; Resync
• Other Study ID Numbers: PRO-FY2020-67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No