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Dietary Nitrate and Muscle Power With Aging

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ClinicalTrials.gov Identifier: NCT03513302
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew R. Coggan, Indiana University

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.

Condition or disease Intervention/treatment Phase
Aging Sarcopenia Dietary Supplement: placebo Dietary Supplement: nitrate Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind, placebo-controlled, crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Nitrate and Muscle Power With Aging
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Arm Intervention/treatment
Placebo Comparator: placebo Dietary Supplement: placebo
2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.
Other Name: Beet It Sport Nitrate 400 placebo

Active Comparator: nitrate Dietary Supplement: nitrate
2 x 70 mL concentrated beet root juice per day for 14 days.
Other Name: Beet It Sport Nitrate 400




Primary Outcome Measures :
  1. Muscle function [ Time Frame: 1 day ]
    Maximal knee extensor speed and power determined using isokinetic dynamometry

  2. Muscle function [ Time Frame: 14 days ]
    Maximal knee extensor speed and power determined using isokinetic dynamometry


Secondary Outcome Measures :
  1. Muscle cGMP [ Time Frame: 1 day ]
    Muscle cyclic guanosine monophosphate concentration

  2. Muscle cGMP [ Time Frame: 14 days ]
    Muscle cyclic guanosine monophosphate concentration


Other Outcome Measures:
  1. Plasma nitrate [ Time Frame: 0,1,2,3 hours after treatment at 1 and 14 days ]
    Plasma nitrate concentrations

  2. Plasma nitrite [ Time Frame: 0,1,2,3 hours after treatment at 1 and 14 days ]
    Plasma nitrite concentrations

  3. Breath nitric oxide [ Time Frame: 0,1,2,3 hours after treatment at 1 and 14 days ]
    Breath nitric oxide level

  4. Perceived fatigue [ Time Frame: 1,7,14 days of treatment ]
    Perceived fatigue questionnaire (PROMIS 8a)

  5. Physical function [ Time Frame: 1,7,14 days of treatment ]
    Physical function questionnaire (PROMIS 20a)

  6. Physical activity [ Time Frame: 1,7,14 days of treatment ]
    Physical activity (total and bouted) from ActiGraph monitors



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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513302


Contacts
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Contact: Richard L Hoffman, MS 3172740648 richoffm@iu.edu

Locations
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United States, Indiana
Indiana University School of Health and Human Sciences Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Richard L Hoffman, MS    317-274-0648    richoffm@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Andrew Coggan, PhD Indiana University School of Medicine

Publications:

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Responsible Party: Andrew R. Coggan, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03513302     History of Changes
Other Study ID Numbers: 1712579448
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Andrew R. Coggan, Indiana University:
nitric oxide

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms