Aging, Nitrate, Endothelial Function and Muscle Oxygenation

May 15, 2016 updated by: Thiago Alvares, Universidade Federal do Rio de Janeiro

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Beetroot gel (dietary nitrate)
Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose
Other: Beetroot-based nutritional gel
100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.
Active Comparator: Placebo gel (nitrate-depleted)
Nutritional gel nitrate-depleted
Other: Placebo
100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in endothelial function as evaluated by the flow-mediated dilation.
Time Frame: Evaluated 120 min after the nutritional intervention
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
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
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
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
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
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
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
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
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
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
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
Evaluated 150 min after the nutritional intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Rio de Janeiro

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15510313.5.0000.5257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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