Nitrate Supplementation and Muscle Blood Flow

January 8, 2019 updated by: Darren P Casey, University of Iowa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Medical Education Building

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

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitrate Rich Beetroot Powder (nitrate)
Dietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely
Dietary supplement: Super Beets
Nitrate rich beetroot powder (10g) acutely
Dietary supplement: Beetroot powder
Nitrate devoid beetroot powder (10g) acutely
Placebo Comparator: Placebo Beetroot Powder
Beetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely
Dietary supplement: Super Beets
Nitrate rich beetroot powder (10g) acutely
Dietary supplement: Beetroot powder
Nitrate devoid beetroot powder (10g) acutely

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits.

Collaborators and Investigators

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

Sponsor

University of Iowa

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 (Actual)

October 10, 2017

Primary Completion (Actual)

February 8, 2018

Study Completion (Actual)

February 8, 2018

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201708795

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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