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Nitrate and Exercise Performance in Middle to Older Aged Adults

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ClinicalTrials.gov Identifier: NCT03371966
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Isagenix International LLC
Information provided by (Responsible Party):
Wake Forest University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: High Nitrate Beetroot Juice Dietary Supplement: Low Nitrate Beetroot Juice Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Chronic Dietary Nitrate Supplementation on Constant Work Rate Exercise in High Functioning Middle Aged and Older Adults
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine


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..




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371966


Locations
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United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
Sponsors and Collaborators
Wake Forest University
Isagenix International LLC
Investigators
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Principal Investigator: Michael H Berry, Ph.D. Wake Forest University

Publications:

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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT03371966     History of Changes
Other Study ID Numbers: WFU-IRB00022914
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University:
Beetroot Juice
Older Adults
Nitrate
Nitrite
Nitric Oxide