AgingNCT03371966
Nitrate and Exercise Performance in Middle to Older Aged Adults
A study testing High Nitrate Beetroot Juice and Low Nitrate Beetroot Juice in people with Aging, run by Wake Forest University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- High Nitrate Beetroot Juice and Low Nitrate Beetroot Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2017to 18 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- tobacco user (smoke or chew)
- participating in another intervention research study
- diabetes (type 1 or 2)
- atrophic gastritis
- hypo-or hyperthyroidism
- gout
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- High Nitrate Beetroot Juice, Low Nitrate Beetroot Juice
- Keywords
- Beetroot Juice, Older Adults, Nitrate, Nitrite, Nitric Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Nitrate Beetroot JuiceDietary 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.
Low Nitrate Beetroot JuiceDietary 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..
| Study group | Role | What they receive |
|---|---|---|
| High Nitrate Beetroot Juice | Active comparator | Beetroot juice high in nitrate will contain approximately 10.0 mmole nitrate per 120 ml. Receives: 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. Receives: Dietary Supplement: Low Nitrate Beetroot Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Work Rate (CWR) Exercise Time
Exercise duration measured as the length of the exercise period at a submaximal exercise work rate.
Measured: Seven days of treatment
Secondary outcomes (4)
Isotime Oxygen Consumption (VO2)
VO2 during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).
Measured: Seven days of treatment
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).
Measured: Seven days of treatment
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).
Measured: Seven days of treatment
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).
Measured: Seven days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start13 Dec 2017
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Isagenix International LLC
- Responsible party
- Sponsor
- Investigators
- Michael H Berry, Ph.D., Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371966
- Sponsor's protocol ID
- WFU-IRB00022914
- Status last verified
- May 2019
- First submitted
- 8 Dec 2017
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18167491Gladwin 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.
PubMed 17089890van 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.
PubMed 19219851Jones 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.
PubMed 24791915Bailey 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.
PubMed 19661447Lansley 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.
PubMed 21471821Cermak 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.
PubMed 22248502Miller 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.
PubMed 22464802Berry 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.
PubMed 25445634Eggebeen 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.
PubMed 26874390Berry 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.
PubMed 32574223
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chronic Dietary Nitrate Supplementation on Constant Work Rate Exercise in High Functioning Middle Aged and Older Adults
- ClinicalTrials.gov ID
- NCT03371966
- Acronym / sponsor ID
- WFU-IRB00022914
- Conditions
- Aging
- Keywords
- Beetroot Juice, Older Adults, Nitrate, Nitrite, Nitric Oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Isagenix International LLC
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Nitrate Beetroot Juice | Active comparator | Dietary Supplement: High Nitrate Beetroot JuiceBeetroot juice high in nitrate will contain approximately 10.0 mmole nitrate per 120 ml. |
| Low Nitrate Beetroot Juice | Placebo comparator | Dietary Supplement: Low Nitrate Beetroot JuiceBeetroot juice low in nitrate will contain approximately 0.5 mmole nitrate per 120 ml. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- tobacco user (smoke or chew)
- participating in another intervention research study
- diabetes (type 1 or 2)
- atrophic gastritis
- hypo-or hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Nitrate Beetroot JuiceHigh 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. | Dietary supplement | High Nitrate Beetroot Juice |
| Low Nitrate Beetroot JuiceLow 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.. | Dietary supplement | Low Nitrate Beetroot Juice |
Primary outcome
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.
4 secondary outcomes
Isotime Oxygen Consumption (VO2)
Time frame: Seven days of treatment
Isotime Borg Rating of Perceived Exertion (RPE)
Time frame: Seven days of treatment
Isotime Systolic Blood Pressure (Systolic BP)
Time frame: Seven days of treatment
Isotime Diastolic Blood Pressure (Systolic BP)
Time frame: Seven days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Background: PubMed 18167491Lundberg 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.
- Background: PubMed 17089890Gladwin 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.
- Background: PubMed 19219851van 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.
- Background: PubMed 24791915Jones 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.
- Background: PubMed 19661447Bailey 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.
- Background: PubMed 21471821Lansley 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.
- Background: PubMed 22248502Cermak 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.
- Background: PubMed 22464802Miller 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.
- Background: PubMed 25445634Berry 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.
- Background: PubMed 26874390Eggebeen 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.
- Derived from this study: PubMed 32574223Berry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Berry, Ph.D. principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Nitrate Beetroot Juice and Low Nitrate Beetroot Juice in people with Aging, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Work Rate (CWR) Exercise Time (time frame: Seven days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371966, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019; AzTrials last refreshed its copy on 1 Nov 2026.