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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03371966
Other study ID # WFU-IRB00022914
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2017
Est. completion date January 18, 2019

Study information

Verified date May 2019
Source Wake Forest University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date January 18, 2019
Est. primary completion date January 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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..

Locations

Country Name City State
United States Wake Forest University Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Isagenix International LLC

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bailey SJ, Winyard P, Vanhatalo A, Blackwell JR, Dimenna FJ, Wilkerson DP, Tarr J, Benjamin N, Jones AM. Dietary nitrate supplementation reduces the O2 cost of low-intensity exercise and enhances tolerance to high-intensity exercise in humans. J Appl Physiol (1985). 2009 Oct;107(4):1144-55. doi: 10.1152/japplphysiol.00722.2009. Epub 2009 Aug 6. — View Citation

Berry MJ, Justus NW, Hauser JI, Case AH, Helms CC, Basu S, Rogers Z, Lewis MT, Miller GD. Dietary nitrate supplementation improves exercise performance and decreases blood pressure in COPD patients. Nitric Oxide. 2015 Aug 1;48:22-30. doi: 10.1016/j.niox.2014.10.007. Epub 2014 Oct 27. — View Citation

Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. — View Citation

Eggebeen J, Kim-Shapiro DB, Haykowsky M, Morgan TM, Basu S, Brubaker P, Rejeski J, Kitzman DW. One Week of Daily Dosing With Beetroot Juice Improves Submaximal Endurance and Blood Pressure in Older Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):428-37. doi: 10.1016/j.jchf.2015.12.013. Epub 2016 Feb 10. — View Citation

Gladwin MT. Role of the red blood cell in nitric oxide homeostasis and hypoxic vasodilation. Adv Exp Med Biol. 2006;588:189-205. Review. — View Citation

Jones AM. Dietary nitrate supplementation and exercise performance. Sports Med. 2014 May;44 Suppl 1:S35-45. doi: 10.1007/s40279-014-0149-y. Review. — View Citation

Lansley KE, Winyard PG, Bailey SJ, Vanhatalo A, Wilkerson DP, Blackwell JR, Gilchrist M, Benjamin N, Jones AM. Acute dietary nitrate supplementation improves cycling time trial performance. Med Sci Sports Exerc. 2011 Jun;43(6):1125-31. doi: 10.1249/MSS.0b013e31821597b4. — View Citation

Lundberg JO, Weitzberg E, Gladwin MT. The nitrate-nitrite-nitric oxide pathway in physiology and therapeutics. Nat Rev Drug Discov. 2008 Feb;7(2):156-67. doi: 10.1038/nrd2466. Review. — View Citation

Miller GD, Marsh AP, Dove RW, Beavers D, Presley T, Helms C, Bechtold E, King SB, Kim-Shapiro D. Plasma nitrate and nitrite are increased by a high-nitrate supplement but not by high-nitrate foods in older adults. Nutr Res. 2012 Mar;32(3):160-8. doi: 10.1016/j.nutres.2012.02.002. — View Citation

van Faassen EE, Bahrami S, Feelisch M, Hogg N, Kelm M, Kim-Shapiro DB, Kozlov AV, Li H, Lundberg JO, Mason R, Nohl H, Rassaf T, Samouilov A, Slama-Schwok A, Shiva S, Vanin AF, Weitzberg E, Zweier J, Gladwin MT. Nitrite as regulator of hypoxic signaling in mammalian physiology. Med Res Rev. 2009 Sep;29(5):683-741. doi: 10.1002/med.20151. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Constant Work Rate (CWR) Exercise Time Exercise duration measured as the length of the exercise period at a submaximal exercise work rate. Seven days of treatment
Secondary Isotime Oxygen Consumption (VO2) VO2 during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime). Seven days of treatment
Secondary Isotime Borg Rating of Perceived Exertion (RPE) RPE during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime). Seven days of treatment
Secondary Isotime Systolic Blood Pressure (Systolic BP) 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
Secondary Isotime Diastolic Blood Pressure (Systolic BP) 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
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