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Completed

NCT Number: NCT04125940

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resync

Dietary Supplement

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.

Resync + Collagen

Dietary Supplement

17g Collagen + 2g Resync + 1g Carbohydrate

Placebo

Other

12oz water + food coloring

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. Change in heart rate from daily baseline with 7.5g Resync

    Time frame: 75-minutes post supplement ingestion

    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.

  2. Change in heart rate from daily baseline with 15g Resync

    Time frame: 75-minutes post supplement ingestion

    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.

  3. Change in heart rate from daily baseline with placebo

    Time frame: 75-minutes post supplement ingestion

    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.

  4. Change in heart rate from daily baseline with 20g Resync+Collagen

    Time frame: 75-minutes post supplement ingestion

    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.

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Resync, LLC

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2019
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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