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CompletedNCT03459027Updated Jan 9, 2019

Nitrate Supplementation and Muscle Blood Flow

An interventional study of Super Beets and Beetroot powder in Vasodilation, Blood Pressure and Active Hyperemia, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by University of Iowa · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vasodilation
  • Blood Pressure
  • Active Hyperemia
  • Aging

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Keywords

  • exercise hyperemia
  • vasodilation
  • nitric oxide
  • dietary nitrate
03

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy older adults 60-80 years of age

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • 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 · Dietary Supplement: Beetroot powder

  • Placebo comparator
    Placebo Beetroot Powder

    Beetroot powder devoid of nitrate (10g) will be mixed in water and administered acutely

    Dietary Supplement: Super Beets · Dietary Supplement: Beetroot powder

Interventions

  • Dietary supplementSuper Beets

    Nitrate rich beetroot powder (10g) acutely

  • Dietary supplementBeetroot powder

    Nitrate devoid beetroot powder (10g) acutely

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits.

06

Study locations

1 site
  • Medical Education Building
    Iowa City, Iowa 52242, United States
07

Registry details

Key details

Study ID
NCT03459027
Lead sponsor
University of Iowa
Responsible party
Darren P Casey (Assistant Professor, University of Iowa) — Principal investigator
First posted
Mar 8, 2018
Start date
Oct 10, 2017
Primary completion
Feb 8, 2018
Completion
Feb 8, 2018
Last update
Jan 9, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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