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Nitrate Supplementation and Muscle Blood Flow

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ClinicalTrials.gov Identifier: NCT03459027
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Darren P Casey, University of Iowa

Brief Summary:
The main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee extension exercise in healthy older adults. All subjects will receive active (rich in dietary nitrate) or placebo (devoid of nitrate) supplementation.

Condition or disease Intervention/treatment Phase
Vasodilation Blood Pressure Active Hyperemia Aging Dietary Supplement: Super Beets Dietary Supplement: Beetroot powder Not Applicable

Detailed Description:
Dietary nitrate (beetroot juice) is reduced to nitrite and nitric oxide within the digestive system of humans. Nitric oxide exerts potent vasodilator effects, which have been shown to reduce blood pressure and enhance exercise economy in humans. This pressure reducing effect may have implications within the regulation of blood flow during dynamic exercise in older adults.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Nitric Oxide Bioavailability and Dynamics of Blood Flow and Vasodilation With Age
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitrate Rich Beetroot Powder (nitrate)
Dietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely
Dietary Supplement: Super Beets
Nitrate rich beetroot powder (10g) acutely

Dietary Supplement: Beetroot powder
Nitrate devoid beetroot powder (10g) acutely

Placebo Comparator: Placebo Beetroot Powder
Beetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely
Dietary Supplement: Super Beets
Nitrate rich beetroot powder (10g) acutely

Dietary Supplement: Beetroot powder
Nitrate devoid beetroot powder (10g) acutely




Primary Outcome Measures :
  1. Change in Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound [ Time Frame: Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits. ]
    Leg blood flow via Doppler ultrasound examined during dynamic knee extension exercise. Change in blood flow in response to dynamic knee exercise will be measured to examine the influence of dietary nitrate.



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy older adults 60-80 years of age

Exclusion Criteria:

  • Hypertension,
  • Smoking,
  • Heart disease,
  • Diabetes,
  • Body mass index (BMI) ≥ 30 kg/m2,
  • Autonomic disorders and other conditions that may alter blood pressure or vascular function
  • Medications that might normally alter blood pressure or vascular function.
  • Older women taking hormone replacement therapy medications.

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): NCT03459027


Locations
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United States, Iowa
Medical Education Building
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa

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Responsible Party: Darren P Casey, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03459027     History of Changes
Other Study ID Numbers: 201708795
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Darren P Casey, University of Iowa:
exercise hyperemia
vasodilation
nitric oxide
dietary nitrate

Additional relevant MeSH terms:
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Hyperemia
Vascular Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents