Cardiovascular Diseases in Old AgeNCT05380167
Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion
A study testing BRJ Nitrate in people with Cardiovascular Diseases in Old Age, run by Wake Forest University at 1 site in United States.
Trial summary
The objective of this study was to determine the chronic effects of beetroot juice supplementation on the acute (90-minute post nitrate consumption) efficacy of converting dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases in Old Age
- What is being tested?
- BRJ Nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 May 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Middle and Older (40-80 year-old) men and women
- Body mass index between 18.5 - 30.0 kg/m2
- Able to provide own transportation to study testing visits
- Able to consume study beverages
- Able to speak and read English
Who cannot join
- Tobacco user (smoke or chew), including e-cigarettes
- Known conditions of: diabetes mellitus (type 1 or 2), atrophic gastritis, hypo- or hyperthyroidism, gout, history of kidney stones, history of hypotension, cardiovascular disease, chronic obstructive pulmonary disease, inflammatory bowel diseases, impaired liver or kidney function
- Current or recent (last 3 months) treatment for cancer
- Current use of the following medications: Phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, medication for hypothyroidism, antacid and heartburn medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: Efficacy and Variability in Plasma Nitrite Levels During Long-term Supplementation With Nitrate Containing Beetroot Juice
The objective of this study was to determine the chronic effects of beetroot juice supplementation on the acute (90-minute post nitrate consumption) efficacy of converting dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults. the investigators were also interested in determining the effect of this intervention on fasting levels of plasma nitrate and nitrite over time. Furthermore, the number of participants classified as "non-responders" was determined based on increases in plasma nitrite achieved using tolerable volumes of beetroot juice by other studies.
- Conditions
- Cardiovascular Diseases in Old Age
- Being tested
- BRJ Nitrate, BRJ Placebo
- Keywords
- beetroot juice, dietary nitrate, plasma nitrite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRJ NitrateDietary supplement
Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate.
BRJ PlaceboDietary supplement
Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate
| Study group | Role | What they receive |
|---|---|---|
| BRJ Nitrate | Experimental | This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate. Receives: Dietary Supplement: BRJ Nitrate |
| BRJ Placebo | Placebo comparator | This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate. Receives: Dietary Supplement: BRJ Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Nitrate
Concentration of nitrate in the plasma obtained at the start of each testing visit
Measured: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Fasting Plasma Nitrite
Concentration of nitrite in the plasma obtained at the start of each testing visit
Measured: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
90 minute plasma Nitrate
Concentration of nitrate in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage
Measured: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
90 minute plasma Nitrite
Concentration of nitrite in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage
Measured: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Sep 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases in Old AgeStudies 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
- Parallel groups
- Model description
- Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Miller, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380167
- Sponsor's protocol ID
- IRB000022922
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Variability in Plasma Nitrite Levels During Long-term Supplementation With Nitrate Containing Beetroot Juice
- ClinicalTrials.gov ID
- NCT05380167
- Acronym / sponsor ID
- IRB000022922
- Conditions
- Cardiovascular Diseases in Old Age
- Keywords
- beetroot juice, dietary nitrate, plasma nitrite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 18 May 2022 (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.
The objective of this study was to determine the chronic effects of beetroot juice supplementation on the acute (90-minute post nitrate consumption) efficacy of converting dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults. the investigators were also interested in determining the effect of this intervention on fasting levels of plasma nitrate and nitrite over time. Furthermore, the number of participants classified as "non-responders" was determined based on increases in plasma nitrite achieved using tolerable volumes of beetroot juice by other studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed.
| Arm | Type | Receives |
|---|---|---|
| BRJ Nitrate | Experimental | Dietary Supplement: BRJ NitrateThis arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate. |
| BRJ Placebo | Placebo comparator | Dietary Supplement: BRJ PlaceboThis arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Middle and Older (40-80 year-old) men and women
- Body mass index between 18.5 - 30.0 kg/m2
- Able to provide own transportation to study testing visits
- Able to consume study beverages
- Able to speak and read English
Key exclusion criteria (4 listed)
- Tobacco user (smoke or chew), including e-cigarettes
- Known conditions of: diabetes mellitus (type 1 or 2), atrophic gastritis, hypo- or hyperthyroidism, gout, history of kidney stones, history of hypotension, cardiovascular disease, chronic obstructive pulmonary disease, inflammatory bowel diseases, impaired liver or kidney function
- Current or recent (last 3 months) treatment for cancer
- Current use of the following medications: Phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, medication for hypothyroidism, antacid and heartburn medications
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 |
|---|---|---|
| BRJ NitrateParticipants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate. | Dietary supplement | BRJ Nitrate |
| BRJ PlaceboParticipants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate | Dietary supplement | BRJ Placebo |
Primary outcome
Fasting Plasma Nitrate
Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrate in the plasma obtained at the start of each testing visit
Fasting Plasma Nitrite
Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrite in the plasma obtained at the start of each testing visit
90 minute plasma Nitrate
Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrate in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage
90 minute plasma Nitrite
Time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrite in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage
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 25 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRJ Nitrate in people with Cardiovascular Diseases in Old Age, run by Wake Forest University 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 5 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 25 May 2022. 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?
Fasting Plasma Nitrate (time frame: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12). The study lists 4 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 25 May 2022; AzTrials last refreshed its copy on 26 Oct 2026.