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

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ClinicalTrials.gov Identifier: NCT03595774
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew R. Coggan, Indiana University

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).

Condition or disease Intervention/treatment Phase
Aging Sarcopenia Dietary Supplement: Beet root juice Phase 1

Detailed Description:

This study consists of four visits that will take a minimum of 15 days to complete.

Study Visit One (Screening) 1-2 hours The purpose of the screening visit is to explain all aspects of the study. The investigators will also determine if individuals can participate in the study. Eligible subjects will undergo a complete medical history and physical exam. They will have their blood drawn, and will provide a urine sample (to determine if they are pregnant). Subjects will also practice the entire neuromuscular function exercise test. During this test, the strength of the subject's muscles will be determined by having them kick, push and/or pull back as hard as they can while their leg is strapped to an exercise device. Blood pressure and heart rate and rhythm will be monitored.

Subjects will be instructed to consume their normal diet throughout the study. However, they will be asked to avoid eating foods high in nitrate such as beets, spinach, and collard greens the evening before each visit. They will be asked to refrain from the use of antibacterial mouthwash, such as Listerine or Cepacol, during the study. Subjects will also be asked to not chew gum or to consume alcohol or food and drinks that contain caffeine for 24 hour before each visit. This includes coffee, tea, chocolate and soft drinks such as Mountain Dew. Finally, they will be asked to fast for 12 hour prior to each study visit.

Study Visit Two - Approximately 5 hours At the beginning of this visit a catheter (small, flexible, sterile plastic tube) will be placed through a vein in one of the subject's arms. This is for collection of blood samples. Blood will be drawn four times during this visit. Each draw will be 6mL or about 1.2 teaspoons. The first blood draw will check nitrate and nitrogen levels. Subjects will then have a breath test to check nitric oxide. They will then drink about 280 mL (about 1 cup) of BRJ. In one trial, this will be a placebo, that is, BRJ from which the essentially all of the nitrate has been removed. In another trial, they will drink BRJ still containing nitrate. In a third trial, they will drink an equal mixture of the placebo and nitrate-containing BRJ. Blood and breath samples will be obtained every hour. Heart rate and blood pressure will be measured at the same times the blood and breath samples are obtained. About 2 hours after ingestion of BRJ (or placebo) subjects will be asked to perform the neuromuscular function test that was practiced during the screening visit. After completing the exercise test one final blood and breath sample will be obtained.

Study Visits Three and Four

The same procedures completed during Study Visit Two will be performed. The order of treatment (placebo vs. lower dose vs. higher dose of nitrate) will be randomized using a computer program. Neither the subjects nor the investigators will know the treatment they receive during each visit until the entire study is completed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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: Dose-response Effect of Dietary Nitrate on Muscle Function in Older Individuals
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Placebo Comparator: Placebo
3.3 mL/kg concentrated beet root juice *depleted of nitrate* Other names: Beet It Sport Nitrate 400 placebo
Dietary Supplement: Beet root juice
Beet root juice
Other Name: Beet It Sport Nitrate 400

Active Comparator: low nitrate

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
Beet root juice
Other Name: Beet It Sport Nitrate 400

Active Comparator: high nitrate

3.3 mL/kg concentrated beet root juice containing nitrate

Other names:Beet It Sport Nitrate 400

Dietary Supplement: Beet root juice
Beet root juice
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


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

  2. Plasma nitrite [ Time Frame: 0, 1, 2 3 hours after treatment ]
    Plasma nitrate concentrations

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



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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): NCT03595774


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 R Coggan, PhD Indiana University School of Medicine

Publications:

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Responsible Party: Andrew R. Coggan, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03595774     History of Changes
Other Study ID Numbers: 1712606816
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 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