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

NCT04125940 | Completed

• 1 other identifier: PRO-FY2020-67
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Resync; Nitrate; Nitrite; Healthy

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Change in heart rate from daily baseline with 7.5g Resync

  75-minutes post supplement ingestion

• 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 20g Resync+Collagen

  75-minutes post supplement ingestion

Study Arms (4)

Placebo-controlled Arm

PLACEBO COMPARATOR

Placebo - 12oz water with food coloring

Other: Placebo

1 serving Resync Arm

ACTIVE COMPARATOR

12oz water + 7.5g Resync

Dietary Supplement: Resync

2 servings Resync Arm

ACTIVE COMPARATOR

12oz water + 15g Resync

Dietary Supplement: Resync

1 servings Resync+Collagen Arm

ACTIVE COMPARATOR

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

Dietary Supplement: Resync + Collagen

Interventions

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.

1 serving Resync Arm; 2 servings Resync Arm

Resync + Collagen DIETARY_SUPPLEMENT

17g Collagen + 2g Resync + 1g Carbohydrate

1 servings Resync+Collagen Arm

Placebo OTHER

12oz water + food coloring

Placebo-controlled Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18 - 29.9 kg/m2
• Non-smoker
• Non-vegan
• Not using nitrate-based dietary supplements

You may not qualify if:

• Diagnosed history of diabetes
• Diagnosed history of cardiovascular disease
• Diagnosed history of neurological disease
• Pregnant females

Sponsors & Collaborators

• University of Memphis: lead
• Resync, LLC: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Interventions

Collagen

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Richard J Bloomer, Ph.D.

  Dean of School of Health Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-Blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of School of Health Studies

Model Details: Single-blind, pre-post ingestion, control

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 14, 2019
• Study Start: October 14, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)