Nitrate Supplementation and Muscle Blood Flow

NCT ID: NCT03459027

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2018-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vasodilation Blood Pressure Active Hyperemia Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nitrate Rich Beetroot Powder (nitrate)

Dietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely

Group Type ACTIVE_COMPARATOR

Super Beets

Intervention Type DIETARY_SUPPLEMENT

Nitrate rich beetroot powder (10g) acutely

Beetroot powder

Intervention Type DIETARY_SUPPLEMENT

Nitrate devoid beetroot powder (10g) acutely

Placebo Beetroot Powder

Beetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely

Group Type PLACEBO_COMPARATOR

Super Beets

Intervention Type DIETARY_SUPPLEMENT

Nitrate rich beetroot powder (10g) acutely

Beetroot powder

Intervention Type DIETARY_SUPPLEMENT

Nitrate devoid beetroot powder (10g) acutely

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Super Beets

Nitrate rich beetroot powder (10g) acutely

Intervention Type DIETARY_SUPPLEMENT

Beetroot powder

Nitrate devoid beetroot powder (10g) acutely

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy older adults 60-80 years of age

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Darren P Casey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Education Building

Iowa City, Iowa, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201708795

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dietary Nitrate for Heart Failure
NCT01682356 COMPLETED PHASE1/PHASE2
The Nitrite and Coronary Flow Study
NCT04354051 COMPLETED PHASE1/PHASE2
Nitrite Infusion Studies
NCT00102271 COMPLETED PHASE1