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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125940
Recruitment Status : Completed
First Posted : October 14, 2019
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Resync, LLC
Information provided by (Responsible Party):
Richard Bloomer, University of Memphis

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Resync Dietary Supplement: Resync + Collagen Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-blind, pre-post ingestion, control
Masking: Single (Participant)
Masking Description: Single-Blind
Primary Purpose: Basic Science
Official Title: Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women
Actual Study Start Date : October 14, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125940


Locations
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United States, Tennessee
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
University of Memphis
Resync, LLC
Investigators
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Principal Investigator: Richard J Bloomer, Ph.D. Dean of School of Health Studies
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Responsible Party: Richard Bloomer, Dean of School of Health Studies, University of Memphis
ClinicalTrials.gov Identifier: NCT04125940    
Other Study ID Numbers: PRO-FY2020-67
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Bloomer, University of Memphis:
Resync
Nitrate
Nitrite
Healthy