Nitrate and Exercise Performance in Middle to Older Aged Adults

May 2, 2019 updated by: Wake Forest University

The Effects of Chronic Dietary Nitrate Supplementation on Constant Work Rate Exercise in High Functioning Middle Aged and Older Adults

Research with young healthy individuals has shown that beetroot juice beverages that contain large amounts of nitrate can improve exercise performance. Currently, it is not know whether the consumption of beetroot juice beverages high in nitrate can improve exercise performance in higher functioning middle- to older-aged adults. Therefore, the purpose of this study is to compare the effect of two different beetroot juice beverages (one high in nitrate and one low in nitrate) on exercise performance in middle- to older-aged adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nitric oxide (NO) has been identified as an important biological messenger involved in a number of physiological processes and is produced from L-arginine and molecular oxygen by NO-synthases or the more recently identified nitrate to nitrite to NO pathway. Dietary nitrate can be found in green leafy vegetables and is particularly abundant in beetroot and has been shown to be a potential ergogenic agent. The nitrate to nitrite to NO pathway has been shown to be involved in a number of physiological processes that could account for the improved exercise response following nitrate ingestion. However, the benefits of nitrate as an ergogenic aid have been shown to be effected by numerous factors that can influence its efficacy. These include age, training level, dosage and the mode, duration and intensity of the exercise.

Research with healthy younger moderately trained adults has repeatedly shown that ingestion of dietary nitrate can reduce the oxygen cost of submaximal exercise and improve exercise performance during high intensity exercise; whereas research with younger more highly trained endurance athletes is equivocal, since some studies have failed to demonstrate an improvement in exercise performance following nitrate ingestion.

The effects of nitrate have also been shown to be influenced by age. It has been documented that there are alterations in NO metabolism in older adults thought to result from impairment of the NO-synthases pathway. The investigators have shown that consumption of a supplement high in nitrate, such as beetroot juice, leads to elevated plasma nitrite levels and may help restore NO metabolism in older adults; whereas a diet high in nitrate without supplementation was insufficient at increasing plasma nitrite levels. The investigators research, along with that of others has shown nitrate supplementation to have positive effects in older adults with chronic diseases. However, research examining the effects of dietary nitrate on exercise performance in healthy older adults is scarce. Presently, it is unclear as to whether nitrate supplementation is beneficial to exercise performance in older adults and there is no data examining the effect of nitrate supplementation on exercise performance in active older adults. Therefore, the purpose of this study is to examine the effect of chronic nitrate supplementation on exercise performance in active higher functioning older adults.

Study Type

Interventional

Enrollment (Actual)

29

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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27109
        • Wake Forest University

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

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Competitive runner or cyclist.
  • Able to pedal a stationary bike.
  • Engage in moderate physical activity for at least 150 minutes per week or engage in strenuous physical activity for at least 75 minutes per week.
  • Able to provide own transportation to study testing visits.
  • Able to provide own transportation to study testing visits.
  • Able to consume study beverages.
  • Willingness to provide informed consent and participate in the intervention.

Exclusion Criteria:

  • tobacco user (smoke or chew)
  • participating in another intervention research study
  • diabetes (type 1 or 2)
  • atrophic gastritis
  • hypo-or hyperthyroidism
  • gout
  • history of kidney stones
  • history of hypotension
  • aversion to the study-related testing procedures
  • allergy/sensitivity/aversion to beetroot beverages
  • medical conditions with contraindications for engaging in the vigorous aerobic exercise
  • current treatment for cancer
  • thyroid disorders,
  • cardiovascular disease,
  • chronic obstructive pulmonary disease,
  • inflammatory bowel diseases
  • impaired liver or kidney function
  • taking phosphodiesterase type 5 inhibitors
  • taking nitroglycerin or nitrate preparations
  • taking proton pump inhibitors
  • taking medication for hypothyroidism

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Nitrate Beetroot Juice
Beetroot juice high in nitrate will contain approximately 10.0 mmole nitrate per 120 ml.
Dietary supplement: High Nitrate Beetroot Juice
High nitrate beetroot juice (120 ml) will be administered for 7 days consecutively followed by a 7 day washout period then 7 consecutive days of low nitrate beetroot juice.
Placebo Comparator: Low Nitrate Beetroot Juice
Beetroot juice low in nitrate will contain approximately 0.5 mmole nitrate per 120 ml.
Dietary supplement: Low Nitrate Beetroot Juice
Low nitrate beetroot juice (120 ml) will be administered for 7 days consecutively followed by a 7 day washout period then 7 consecutive days of high nitrate beetroot juice..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Work Rate (CWR) Exercise Time
Time Frame: Seven days of treatment
Exercise duration measured as the length of the exercise period at a submaximal exercise work rate.
Seven days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isotime Oxygen Consumption (VO2)
Time Frame: Seven days of treatment
VO2 during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).
Seven days of treatment
Isotime Borg Rating of Perceived Exertion (RPE)
Time Frame: Seven days of treatment
RPE during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).
Seven days of treatment
Isotime Systolic Blood Pressure (Systolic BP)
Time Frame: Seven days of treatment
Systolic BP during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).
Seven days of treatment
Isotime Diastolic Blood Pressure (Systolic BP)
Time Frame: Seven days of treatment
Diastolic BP during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).
Seven days of treatment

Collaborators and Investigators

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

Sponsor

Wake Forest University

Collaborators

Isagenix International LLC

Investigators

  • Principal Investigator: Michael H Berry, Ph.D., Wake Forest University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 13, 2017

Primary Completion (Actual)

January 18, 2019

Study Completion (Actual)

January 18, 2019

Study Registration Dates

First Submitted

December 8, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WFU-IRB00022914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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