Clinical trial NCT03371966: Nitrate and Exercise Performance in Middle to Older Aged Adults
Official title: The Effects of Chronic Dietary Nitrate Supplementation on Constant Work Rate Exercise in High Functioning Middle Aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Beetroot Juice
Older Adults
Nitrate
Nitrite
Nitric Oxide
Lead sponsor: Wake Forest University
Sponsor class: OTHER
Collaborators: name: Isagenix International LLC
First posted: 2017-12-13
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Constant Work Rate (CWR) Exercise Time
timeFrame: Seven days of treatment
Secondary outcomes:
measure: Isotime Oxygen Consumption (VO2)
timeFrame: Seven days of treatment
measure: Isotime Borg Rating of Perceived Exertion (RPE)
timeFrame: Seven days of treatment
measure: Isotime Systolic Blood Pressure (Systolic BP)
timeFrame: Seven days of treatment
measure: Isotime Diastolic Blood Pressure (Systolic BP)
timeFrame: Seven days of treatment
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Michael H Berry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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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.
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citation: Berry MJ, Miller GD, Kim-Shapiro DB, Fletcher MS, Jones CG, Gauthier ZD, Collins SL, Basu S, Heinrich TM. A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults. PLoS One. 2020 Jun 23;15(6):e0235047. doi: 10.1371/journal.pone.0235047. eCollection 2020.