AgingNCT02772900
Aging, Nitrate, Endothelial Function and Muscle Oxygenation
A study testing Beetroot-based nutritional gel in people with Aging and Hypertension, run by Universidade Federal do Rio de Janeiro.
Trial summary
Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO bioconversion, which may promote beneficial effects on vascular health. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Aging, Hypertension, Dyslipidemia
- What is being tested?
- Beetroot-based nutritional gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly participants (≥ 65 years)
- Taking between 1 and 3 anti-hypertensive medications for high blood pressure;
- Elevated triglycerides ≥ 150 mg/dL;
- Reduced HDL-cholesterol < 50 mg/dL for women and < 40 mg/dL for men;
- Elevated waist circumference by population definition (male: > 102 cm and female: > 88 cm).
- Exclusion Criteria: elevated fasting glucose (≥ 100 mg/dL), smoking, beetroot allergy, unwillingness to avoid beetroot products during the entire study, other chronic diseases (diabetes, liver disease, etc.), or acutely ill.
Who cannot join
None listed.
About this study
Official title: Effect of a Beetroot-based Nutritional Gel on Vascular Function and Forearm Muscle Oxygenation Responses in the Elderly at Cardiometabolic Risk
Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO bioconversion, which may promote beneficial effects on vascular health. The present study evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function, arterial stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ), augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep), arterial compliance (AC), muscle oxygenation and function were measured 90 min after interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after interventions.
- Conditions
- Aging, Hypertension, Dyslipidemia, Abdominal Obesity
- Being tested
- Beetroot-based nutritional gel, Placebo
- Keywords
- Aging, Beetroot, Dietary Nitrate, Functional Food, Vascular Function
- Medical subject headings
- Hypertension, Dyslipidemias, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot-based nutritional gelOther
100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.
PlaceboOther
100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot gel (dietary nitrate) | Active comparator | Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose Receives: Other: Beetroot-based nutritional gel |
| Placebo gel (nitrate-depleted) | Active comparator | Nutritional gel nitrate-depleted Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endothelial function as evaluated by the flow-mediated dilation.
Measured: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the peak wave velocity.
Measured: Evaluated 120 min after the nutritional intervention
Changes in the clinical blood pressure
Measured: Evaluated before, 120 min and 180 min after the nutritional intervention
Changes in the muscle oxygenation as evaluated by the levels of oxygenated
Measured: Evaluated 150 min after the nutritional intervention
Changes in the muscle function as evaluated by the maximal voluntary contraction of the forearm muscle
Measured: Evaluated before and 180 min after the nutritional intervention
Changes in endothelial function as evaluated by blood flow velocity
Measured: Evaluated 120 min after the nutritional intervention
Changes in endothelial function as evaluated by reactive hyperemia.
Measured: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by augmentation index
Measured: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the stiffness parameter
Measured: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus
Measured: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the arterial compliance.
Measured: Evaluated 120 min after the nutritional intervention
Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin
Measured: Evaluated 150 min after the nutritional intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Thiago Alvares, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772900
- Sponsor's protocol ID
- 15510313.5.0000.5257
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Beetroot-based Nutritional Gel on Vascular Function and Forearm Muscle Oxygenation Responses in the Elderly at Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT02772900
- Acronym / sponsor ID
- 15510313.5.0000.5257
- Conditions
- Aging, Hypertension, Dyslipidemia, Abdominal Obesity
- Keywords
- Aging, Beetroot, Dietary Nitrate, Functional Food, Vascular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- 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.
Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO bioconversion, which may promote beneficial effects on vascular health. The present study evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function, arterial stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ), augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep), arterial compliance (AC), muscle oxygenation and function were measured 90 min after interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot gel (dietary nitrate) | Active comparator | Other: Beetroot-based nutritional gelBeetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose |
| Placebo gel (nitrate-depleted) | Active comparator | Other: PlaceboNutritional gel nitrate-depleted |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Elderly participants (≥ 65 years)
- Taking between 1 and 3 anti-hypertensive medications for high blood pressure;
- Elevated triglycerides ≥ 150 mg/dL;
- Reduced HDL-cholesterol < 50 mg/dL for women and < 40 mg/dL for men;
- Elevated waist circumference by population definition (male: > 102 cm and female: > 88 cm).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Beetroot-based nutritional gel100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate. | Other | Beetroot gel (dietary nitrate) |
| Placebo100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate. | Other | Placebo gel (nitrate-depleted) |
Primary outcome
Changes in endothelial function as evaluated by the flow-mediated dilation.
Time frame: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the peak wave velocity.
Time frame: Evaluated 120 min after the nutritional intervention
Changes in the clinical blood pressure
Time frame: Evaluated before, 120 min and 180 min after the nutritional intervention
Changes in the muscle oxygenation as evaluated by the levels of oxygenated
Time frame: Evaluated 150 min after the nutritional intervention
Changes in the muscle function as evaluated by the maximal voluntary contraction of the forearm muscle
Time frame: Evaluated before and 180 min after the nutritional intervention
Changes in endothelial function as evaluated by blood flow velocity
Time frame: Evaluated 120 min after the nutritional intervention
Changes in endothelial function as evaluated by reactive hyperemia.
Time frame: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by augmentation index
Time frame: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the stiffness parameter
Time frame: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus
Time frame: Evaluated 120 min after the nutritional intervention
Changes in the arterial stiffness as evaluated by the arterial compliance.
Time frame: Evaluated 120 min after the nutritional intervention
Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin
Time frame: Evaluated 150 min after the nutritional intervention
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 17 May 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot-based nutritional gel in people with Aging and Hypertension, run by Universidade Federal do Rio de Janeiro.
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 6 inclusion and 0 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Changes in endothelial function as evaluated by the flow-mediated dilation. (time frame: Evaluated 120 min after the nutritional intervention). 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 17 May 2016.