Nitrate and Exercise Performance in Middle to Older Aged Adults

NCT03371966 | Completed

• 1 other identifier: WFU-IRB00022914
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Beetroot Juice; Older Adults; Nitrate; Nitrite; Nitric Oxide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Isotime Oxygen Consumption (VO2)

  Seven days of treatment

• Isotime Borg Rating of Perceived Exertion (RPE)

  Seven days of treatment

• Isotime Systolic Blood Pressure (Systolic BP)

  Seven days of treatment

• Isotime Diastolic Blood Pressure (Systolic BP)

  Seven days of treatment

Study Arms (2)

High Nitrate Beetroot Juice

ACTIVE COMPARATOR

Beetroot juice high in nitrate will contain approximately 10.0 mmole nitrate per 120 ml.

Dietary Supplement: High Nitrate Beetroot Juice

Low Nitrate Beetroot Juice

PLACEBO COMPARATOR

Beetroot juice low in nitrate will contain approximately 0.5 mmole nitrate per 120 ml.

Dietary Supplement: Low Nitrate Beetroot Juice

Interventions

High Nitrate Beetroot Juice DIETARY_SUPPLEMENT

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.

High Nitrate Beetroot Juice

Low Nitrate Beetroot Juice DIETARY_SUPPLEMENT

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..

Low Nitrate Beetroot Juice

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Wake Forest University: lead
• Isagenix International LLC: collaborator

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (11)

• 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.

  PMID: 18167491 BACKGROUND

• Gladwin MT. Role of the red blood cell in nitric oxide homeostasis and hypoxic vasodilation. Adv Exp Med Biol. 2006;588:189-205. doi: 10.1007/978-0-387-34817-9_17.

  PMID: 17089890 BACKGROUND

• 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.

  PMID: 19219851 BACKGROUND

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

  PMID: 24791915 BACKGROUND

• 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.

  PMID: 19661447 BACKGROUND

• 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.

  PMID: 21471821 BACKGROUND

• 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. doi: 10.1123/ijsnem.22.1.64.

  PMID: 22248502 BACKGROUND

• 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.

  PMID: 22464802 BACKGROUND

• 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.

  PMID: 25445634 BACKGROUND

• 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.

  PMID: 26874390 BACKGROUND

• 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.

  PMID: 32574223 DERIVED

Study Officials

• Michael H Berry, Ph.D.

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: December 13, 2017
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)