ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 148 studies in Aneurysm with a site in United States — 31 open to participants now, 38 under way, none of them phase 3. Aneurysm · United States.

Enrollment
97th of 111
10 · median 60
Started
2017
with 6 others
No phase
66 of 148
18 open now
Registered
101st of 148
by date

Among the 148 studies in Aneurysm with a site in United States, this one is the 97th largest by enrollment of the 111 interventional ones, is one of 7 that started in 2017, is one of 66 with no phase, and was the 101st registered.

By phase

148 studies; the count open now beside each. This study's row is marked.

No phasethis study66 · 18 open
Observational33 · 6 open
Phase 124 · 2 open
Phase 29 · 2 open
Phase 48 · 2 open
Other kind4 · 0 open
Phase 1/23 · 1 open
Phase 31 · 0 open

By the year they started

First in 1997; this study’s year is marked. 7 started in 2017.

Size and results

Median enrollment 60 across the 111 interventional studies, 114 across the 33 observational. Of the 91 that completed or were terminated, 35 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 148 studies in Aneurysm with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • Vasodilation
  • Blood Pressure
  • Active Hyperemia
  • Aging

Browse trials for

Keywords

  • exercise hyperemia
  • vasodilation
  • nitric oxide
  • dietary nitrate
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy older adults 60-80 years of age

Exclusion criteria

Exclusion Criteria:

  • Hypertension,
  • Smoking,
  • Heart disease,
  • Diabetes,
  • (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

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

06

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.

07

Study locations

1 site
  • Medical Education Building
    Iowa City, Iowa 52242, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Feb 2018, 3 months.

Of 45 non-industry interventional studies with no phase under Aneurysm, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 12. This study's 3 months is below that.

Counting every sponsor, half of 83 studies reached it within 45 months; a quarter within 19 and three quarters within 134.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2017
First posted
Mar 8, 2018
StartActual
Oct 10, 2017
Primary completionActual
Feb 8, 2018
CompletionActual
Feb 8, 2018
Last update
Jan 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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Discussion

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