Dietary Nitrate and Muscle Power With Aging

NCT03513302 | Completed Results

• 1 other identifier: 1712579448
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if drinking beetroot juice (BRJ) is beneficial for aging patients. We hope to determine the effect of BRJ on exercise performance. BRJ improves exercise performance in athletes and normal people. We are trying to determine if BRJ improves exercise performance in aging patients. We will be comparing the effects of BRJ versus the effects of a placebo (BRJ without the nitrates that are naturally occurring in beets and other similar foods). It is thought that the benefits of BRJ may come from its natural nitrate content. Although BRJ is available for purchase in grocery stores, for the purposes of this study it is considered investigational, which means that it has not been approved as a medical therapy.

Conditions

Aging; Sarcopenia

Keywords

nitric oxide

Outcome Measures

Primary Outcomes (4)

• Maximal Knee Extension Velocity

  \*Maximal\* knee extension velocity was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 radians per second on an isokinetic dynamometer (device that controls velocity while measuring torque). Peak power at each velocity was calculated by multiplying the measured torque by that velocity, then a parabolic function was fit to these calculated data to predict \*maximal\* knee extensor velocity. Higher values are better.

  1 day

• Muscle Knee Extensor Power

  This outcome was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 radians per second on an isokinetic dynamometer (device that controls velocity while measuring torque). \*Peak\* power at each velocity was calculated by multiplying the measured torque by that velocity, then a parabolic function was fit to these calculated data to predict \*maximal\* knee extensor power. Higher values are better.

  1 day

• Maximal Knee Extension Velocity

  \*Maximal\* knee extension velocity was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 rad/s on an isokinetic dynamometer (device that controls velocity while measuring torque). Peak power at each velocity was calculated by multiplying the measured torque by that velocity, then \*maximal\* knee extensor velocity was determined by fitting a parabolic function to these data (\*maximal\* knee extension velocity = 2 x fitted velocity at which \*maximal\* power is developed). Higher values are better.

  14 days

• Maximal Knee Extension Power

  \*Maximal\* knee extension power was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 rad/s on an isokinetic dynamometer (device that controls velocity while measuring torque). \*Peak\* power at each velocity was calculated by multiplying the measured torque by that velocity, then \*maximal\* power was determined by fitting a parabolic function to these data. Higher values are better.

  14 days

Other Outcomes (6)

• Plasma Nitrate

  0,1,2,3 hours after treatment at 1 day

• Plasma Nitrate

  0,1,2,3 hours after treatment at 14 days

• Plasma Nitrite

  0,1,2,3 hours after treatment at 1 day

Study Arms (2)

placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo

nitrate

ACTIVE COMPARATOR

Dietary Supplement: nitrate

Interventions

placebo DIETARY_SUPPLEMENT

2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.

Also known as: Beet It Sport Nitrate 400 placebo

placebo

nitrate DIETARY_SUPPLEMENT

2 x 70 mL concentrated beet root juice per day for 14 days.

Also known as: Beet It Sport Nitrate 400

nitrate

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• In good health, as determined by the investigator's review of history (provided by subject at screening visit), physical examination, and routine blood and urine tests (done at screening visit)

You may not qualify if:

• Men and women \<65 or \>79 years of age
• Unable to provide informed consent
• Currently pregnant or lactating (given the age range for the study, verbal confirmation by subject is believed to be sufficient)
• Current smokers
• Significant orthopedic limitations or other contraindications to strenuous exercise
• Those taking phosphodiesterase inhibitors (e.g., Viagra)
• Those taking proton pump inhibitors, antacids, xanthine oxidase inhibitors, or on hormone replacement therapy
• Those taking anti-coagulants (e.g., Coumadin) or on anti-platelet therapy
• History of neuromuscular disease (e.g., cervical spondylotic radiculomyelpathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies), cardiovascular disease (e.g., \> stage I hypertension, heart failure, myocardial infarction/ischemia, significant myocardial or pericardial diseases (e.g. amyloidosis, constriction), moderate or severe valvular disease, renal disease, liver disease, or anemia

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Health and Human Sciences

Indianapolis, Indiana, 46202, United States

Location

Related Publications (7)

• Coggan AR. Dietary Nitrate and Muscle Function in Humans: Acute versus Chronic Mechanisms. Med Sci Sports Exerc. 2018 Apr;50(4):874. doi: 10.1249/MSS.0000000000001489. No abstract available.

  PMID: 29547495 BACKGROUND

• Coggan AR, Broadstreet SR, Mikhalkova D, Bole I, Leibowitz JL, Kadkhodayan A, Park S, Thomas DP, Thies D, Peterson LR. Dietary nitrate-induced increases in human muscle power: high versus low responders. Physiol Rep. 2018 Jan;6(2):e13575. doi: 10.14814/phy2.13575.

  PMID: 29368802 BACKGROUND

• Coggan AR, Broadstreet SR, Mahmood K, Mikhalkova D, Madigan M, Bole I, Park S, Leibowitz JL, Kadkhodayan A, Thomas DP, Thies D, Peterson LR. Dietary Nitrate Increases VO2peak and Performance but Does Not Alter Ventilation or Efficiency in Patients With Heart Failure With Reduced Ejection Fraction. J Card Fail. 2018 Feb;24(2):65-73. doi: 10.1016/j.cardfail.2017.09.004. Epub 2017 Sep 12.

  PMID: 28916479 BACKGROUND

• Coggan AR, Peterson LR. Dietary Nitrate and Skeletal Muscle Contractile Function in Heart Failure. Curr Heart Fail Rep. 2016 Aug;13(4):158-65. doi: 10.1007/s11897-016-0293-9.

  PMID: 27271563 BACKGROUND

• Rimer EG, Peterson LR, Coggan AR, Martin JC. Increase in Maximal Cycling Power With Acute Dietary Nitrate Supplementation. Int J Sports Physiol Perform. 2016 Sep;11(6):715-720. doi: 10.1123/ijspp.2015-0533. Epub 2016 Aug 24.

  PMID: 26641379 BACKGROUND

• Coggan AR, Leibowitz JL, Spearie CA, Kadkhodayan A, Thomas DP, Ramamurthy S, Mahmood K, Park S, Waller S, Farmer M, Peterson LR. Acute Dietary Nitrate Intake Improves Muscle Contractile Function in Patients With Heart Failure: A Double-Blind, Placebo-Controlled, Randomized Trial. Circ Heart Fail. 2015 Sep;8(5):914-20. doi: 10.1161/CIRCHEARTFAILURE.115.002141. Epub 2015 Jul 15.

  PMID: 26179185 BACKGROUND

• Coggan AR, Leibowitz JL, Kadkhodayan A, Thomas DP, Ramamurthy S, Spearie CA, Waller S, Farmer M, Peterson LR. Effect of acute dietary nitrate intake on maximal knee extensor speed and power in healthy men and women. Nitric Oxide. 2015 Aug 1;48:16-21. doi: 10.1016/j.niox.2014.08.014. Epub 2014 Sep 6.

  PMID: 25199856 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Results Point of Contact

• Title: Dr. Andrew Coggan
• Organization: Indiana University Indianapolis

acoggan@iu.edu

3172740656

Study Officials

• Andrew Coggan, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blind, placebo-controlled, crossover

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: March 1, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)