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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Resync
* Dietary Supplement: Resync + Collagen
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single-blind, pre-post ingestion, control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo-controlled Arm<br>Placebo - 12oz water with food coloring | Other: Placebo<br>* 12oz water + food coloring<br>|
| Active Comparator: 1 serving Resync Arm<br>12oz water + 7.5g Resync | Dietary Supplement: Resync<br>* 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.<br>|
| Active Comparator: 2 servings Resync Arm<br>12oz water + 15g Resync | Dietary Supplement: Resync<br>* 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.<br>|
| Active Comparator: 1 servings Resync+Collagen Arm<br>12oz water + 17g collagen + 2g Resync + 1g Carbohydrates | Dietary Supplement: Resync + Collagen<br>* 17g Collagen + 2g Resync + 1g Carbohydrate<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resync, Nitrate, Nitrite, Healthy