HealthyNCT04125940
Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women
A study testing Resync and Resync + Collagen in people with Healthy, run by University of Memphis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Resync and Resync + Collagen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18 - 29.9 kg/m2
- Non-smoker
- Non-vegan
- Not using nitrate-based dietary supplements
Who cannot join
- Diagnosed history of diabetes
- Diagnosed history of cardiovascular disease
- Diagnosed history of neurological disease
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Resync, Resync + Collagen, Placebo
- Keywords
- Resync, Nitrate, Nitrite, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResyncDietary 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 + CollagenDietary supplement
17g Collagen + 2g Resync + 1g Carbohydrate
PlaceboOther
12oz water + food coloring
| Study group | Role | What they receive |
|---|---|---|
| Placebo-controlled Arm | Placebo comparator | Placebo - 12oz water with food coloring Receives: Other: Placebo |
| 1 serving Resync Arm | Active comparator | 12oz water + 7.5g Resync Receives: Dietary Supplement: Resync |
| 2 servings Resync Arm | Active comparator | 12oz water + 15g Resync Receives: Dietary Supplement: Resync |
| 1 servings Resync+Collagen Arm | Active comparator | 12oz water + 17g collagen + 2g Resync + 1g Carbohydrates Receives: Dietary Supplement: Resync + Collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 75-minutes post supplement ingestion
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 75-minutes post supplement ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start14 Oct 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind, pre-post ingestion, control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Resync, LLC
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard J Bloomer, Ph.D., Principal investigator, Dean of School of Health Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125940
- Sponsor's protocol ID
- PRO-FY2020-67
- Status last verified
- Apr 2021
- First submitted
- 8 Oct 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women
- ClinicalTrials.gov ID
- NCT04125940
- Acronym / sponsor ID
- PRO-FY2020-67
- Conditions
- Healthy
- Keywords
- Resync, Nitrate, Nitrite, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Resync, LLC
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Single-blind, pre-post ingestion, control
| Arm | Type | Receives |
|---|---|---|
| Placebo-controlled Arm | Placebo comparator | Other: PlaceboPlacebo - 12oz water with food coloring |
| 1 serving Resync Arm | Active comparator | Dietary Supplement: Resync12oz water + 7.5g Resync |
| 2 servings Resync Arm | Active comparator | Dietary Supplement: Resync12oz water + 15g Resync |
| 1 servings Resync+Collagen Arm | Active comparator | Dietary Supplement: Resync + Collagen12oz water + 17g collagen + 2g Resync + 1g Carbohydrates |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 18 - 29.9 kg/m2
- Non-smoker
- Non-vegan
- Not using nitrate-based dietary supplements
Key exclusion criteria (4 listed)
- Diagnosed history of diabetes
- Diagnosed history of cardiovascular disease
- Diagnosed history of neurological disease
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResyncThe 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. | Dietary supplement | 1 serving Resync Arm, 2 servings Resync Arm |
| Resync + Collagen17g Collagen + 2g Resync + 1g Carbohydrate | Dietary supplement | 1 servings Resync+Collagen Arm |
| Placebo12oz water + food coloring | Other | Placebo-controlled Arm |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Change in heart rate from daily baseline with 7.5g Resync
Time frame: 75-minutes post supplement ingestion
Change in heart rate from daily baseline with 15g Resync
Time frame: 75-minutes post supplement ingestion
Change in heart rate from daily baseline with placebo
Time frame: 75-minutes post supplement ingestion
Change in heart rate from daily baseline with 20g Resync+Collagen
Time frame: 75-minutes post supplement ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Bloomer, Ph.D. principal investigator
Dean of School of Health Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resync and Resync + Collagen in people with Healthy, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood nitrate+nitrite levels from daily baseline with 7.5g Resync (time frame: 75-minutes post supplement ingestion). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.