NCT03459027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

October 11, 2017

Last Update Submit

January 8, 2019

Conditions

Keywords

exercise hyperemiavasodilationnitric oxidedietary nitrate

Outcome Measures

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.

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

Study Arms (2)

Nitrate Rich Beetroot Powder (nitrate)

ACTIVE COMPARATOR

Dietary nitrate in the form of beetroot powder (10g) mixed in water will be administered acutely

Dietary Supplement: Super BeetsDietary Supplement: Beetroot powder

Placebo Beetroot Powder

PLACEBO COMPARATOR

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

Dietary Supplement: Super BeetsDietary Supplement: Beetroot powder

Interventions

Super BeetsDIETARY_SUPPLEMENT

Nitrate rich beetroot powder (10g) acutely

Nitrate Rich Beetroot Powder (nitrate)Placebo Beetroot Powder
Beetroot powderDIETARY_SUPPLEMENT

Nitrate devoid beetroot powder (10g) acutely

Nitrate Rich Beetroot Powder (nitrate)Placebo Beetroot Powder

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy older adults 60-80 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Education Building

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

AneurysmHyperemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2017

First Posted

March 8, 2018

Study Start

October 10, 2017

Primary Completion

February 8, 2018

Study Completion

February 8, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations