Back to resultsNitrate Supplementation and Muscle Blood Flow
Primary Purpose
Vasodilation, Blood Pressure, Active Hyperemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Super Beets
Beetroot powder
Sponsored by
About this trial
This is an interventional basic science trial for Vasodilation focused on measuring exercise hyperemia, vasodilation, nitric oxide, dietary nitrate
Eligibility 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.
Sites / Locations
- Medical Education Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitrate Rich Beetroot Powder (nitrate)
Placebo Beetroot Powder
Arm Description
Dietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely
Beetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely
Outcomes
Primary Outcome Measures
Change in Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03459027
Brief Title
Nitrate Supplementation and Muscle Blood Flow
Official Title
Nitric Oxide Bioavailability and Dynamics of Blood Flow and Vasodilation With Age
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasodilation, Blood Pressure, Active Hyperemia, Aging
Keywords
exercise hyperemia, vasodilation, nitric oxide, dietary nitrate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitrate Rich Beetroot Powder (nitrate)
Arm Type
Active Comparator
Arm Description
Dietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely
Arm Title
Placebo Beetroot Powder
Arm Type
Placebo Comparator
Arm Description
Beetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely
Intervention Type
Dietary Supplement
Intervention Name(s)
Super Beets
Intervention Description
Nitrate rich beetroot powder (10g) acutely
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot powder
Intervention Description
Nitrate devoid beetroot powder (10g) acutely
Primary Outcome Measure Information:
Title
Change in Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound
Description
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.
Time Frame
Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Medical Education Building
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
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Nitrate Supplementation and Muscle Blood Flow
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