VasodilationNCT03459027
Nitrate Supplementation and Muscle Blood Flow
A study testing Super Beets and Beetroot powder in people with Vasodilation and Blood Pressure, run by University of Iowa at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee extension exercise in healthy older adults. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasodilation, Blood Pressure, Active Hyperemia
- What is being tested?
- Super Beets and Beetroot powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 8 Feb 2018
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy older adults 60-80 years of age
Who cannot join
- Hypertension,
- Smoking,
- Heart disease,
- Diabetes,
- Body mass index (BMI) ≥ 30 kg/m2,
- Autonomic disorders and other conditions that may alter blood pressure or vascular function
- Medications that might normally alter blood pressure or vascular function.
- Older women taking hormone replacement therapy medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitric Oxide Bioavailability and Dynamics of Blood Flow and Vasodilation With Age
The main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee extension exercise in healthy older adults. All subjects will receive active (rich in dietary nitrate) or placebo (devoid of nitrate) supplementation.
Read the detailed description
Dietary nitrate (beetroot juice) is reduced to nitrite and nitric oxide within the digestive system of humans. Nitric oxide exerts potent vasodilator effects, which have been shown to reduce blood pressure and enhance exercise economy in humans. This pressure reducing effect may have implications within the regulation of blood flow during dynamic exercise in older adults.
- Conditions
- Vasodilation, Blood Pressure, Active Hyperemia, Aging
- Being tested
- Super Beets, Beetroot powder
- Keywords
- exercise hyperemia, vasodilation, nitric oxide, dietary nitrate
- Medical subject headings
- Aneurysm, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super BeetsDietary supplement
Nitrate rich beetroot powder (10g) acutely
Beetroot powderDietary supplement
Nitrate devoid beetroot powder (10g) acutely
| Study group | Role | What they receive |
|---|---|---|
| Nitrate Rich Beetroot Powder (nitrate) | Active comparator | Dietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely Receives: Dietary Supplement: Super Beets; Dietary Supplement: Beetroot powder |
| Placebo Beetroot Powder | Placebo comparator | Beetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely Receives: Dietary Supplement: Super Beets; Dietary Supplement: Beetroot powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound
Leg blood flow via Doppler ultrasound examined during dynamic knee extension exercise. Change in blood flow in response to dynamic knee exercise will be measured to examine the influence of dietary nitrate.
Measured: Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start10 Oct 2017
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasodilationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren P Casey, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459027
- Sponsor's protocol ID
- 201708795
- Status last verified
- Jan 2019
- First submitted
- 11 Oct 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide Bioavailability and Dynamics of Blood Flow and Vasodilation With Age
- ClinicalTrials.gov ID
- NCT03459027
- Acronym / sponsor ID
- 201708795
- Conditions
- Vasodilation, Blood Pressure, Active Hyperemia, Aging
- Keywords
- exercise hyperemia, vasodilation, nitric oxide, dietary nitrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 8 Mar 2018 (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 main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee extension exercise in healthy older adults. All subjects will receive active (rich in dietary nitrate) or placebo (devoid of nitrate) supplementation.
Detailed description
Dietary nitrate (beetroot juice) is reduced to nitrite and nitric oxide within the digestive system of humans. Nitric oxide exerts potent vasodilator effects, which have been shown to reduce blood pressure and enhance exercise economy in humans. This pressure reducing effect may have implications within the regulation of blood flow during dynamic exercise in older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate Rich Beetroot Powder (nitrate) | Active comparator | Dietary Supplement: Super Beets, Dietary Supplement: Beetroot powderDietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely |
| Placebo Beetroot Powder | Placebo comparator | Dietary Supplement: Super Beets, Dietary Supplement: Beetroot powderBeetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy older adults 60-80 years of age
Key exclusion criteria (8 listed)
- Hypertension,
- Smoking,
- Heart disease,
- Diabetes,
- Body mass index (BMI) ≥ 30 kg/m2,
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 |
|---|---|---|
| Super BeetsNitrate rich beetroot powder (10g) acutely | Dietary supplement | Nitrate Rich Beetroot Powder (nitrate), Placebo Beetroot Powder |
| Beetroot powderNitrate devoid beetroot powder (10g) acutely | Dietary supplement | Nitrate Rich Beetroot Powder (nitrate), Placebo Beetroot Powder |
Primary outcome
Change in Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound
Time frame: Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits.
Leg blood flow via Doppler ultrasound examined during dynamic knee extension exercise. Change in blood flow in response to dynamic knee exercise will be measured to examine the influence of dietary nitrate.
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 9 Jan 2019.
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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 Super Beets and Beetroot powder in people with Vasodilation and Blood Pressure, run by University of Iowa 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 1 inclusion and 8 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 9 Jan 2019. 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 Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound (time frame: Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits.). 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 9 Jan 2019.