Dose-response Effect of Dietary Nitrate on Muscle Function in Older Individuals

NCT03595774 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 1712606816
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Nitrate is a naturally-occurring substance found in foods, especially green leafy vegetables and beets. Increasing nitrate intake (by drinking beetroot juice (BRJ) has been shown to improve muscle function young and middle-aged subjects, athletes, and patients with heart failure. The purpose of this study is to determine whether dietary nitrate provides a similar benefit in older individuals, and if so, the optimal dose. We will be comparing the effects of ingesting BRJ containing a smaller or greater amount of nitrate versus the effects of a placebo (BRJ from which the nitrate has been removed).

Conditions

Aging; Sarcopenia

Keywords

nitric oxide

Outcome Measures

Primary Outcomes (2)

• Maximal Knee Extensor Velocity

  Maximal knee extensor velocity determined using isokinetic dynamometry

  1 day

• Maximal Knee Extensor Power

  Maximal knee extensor power determined using isokinetic dynamometry

  1 day

Secondary Outcomes (3)

• Plasma Nitrite

  0, 1, 2, 3 h after ingestion

• Plasma Nitrate

  0, 1, 2, 3 h after ingestion

• Breath Nitric Oxide

  0, 1, 2, 3 h after ingestion

Study Arms (3)

Placebo

PLACEBO COMPARATOR

3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* Other names: Beet It Sport Nitrate 400 placebo

Dietary Supplement: Beet root juice

low nitrate

ACTIVE COMPARATOR

1.55 mL/kg concentrated beet root juice depleted of nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* Other names: Beet It Sport Nitrate 400 placebo + Beet It Sport Nitrate 400

Dietary Supplement: Beet root juice

high nitrate

ACTIVE COMPARATOR

3.3 mL/kg concentrated beet root juice containing nitrate Other names:Beet It Sport Nitrate 400

Dietary Supplement: Beet root juice

Interventions

Beet root juice DIETARY_SUPPLEMENT

Beet root juice

Also known as: Beet It Sport Nitrate 400

Placebo; high nitrate; low 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 (6)

• 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, 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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

acoggan@iu.edu

3172740656

Study Officials

• Andrew R 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: phase 1
• 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: July 11, 2018
• First Posted: July 23, 2018
• Study Start: September 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)