Nitrate Supplementation and Muscle Blood Flow

Sponsor

University of Iowa (Other)

Overall Status

Completed

CT.gov ID

NCT03459027

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vasodilation Blood Pressure Active Hyperemia Aging	Dietary Supplement: Super Beets Dietary Supplement: Beetroot powder	N/A

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.

Study Design

Study Type:

Interventional

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 :

Oct 10, 2017

Actual Primary Completion Date :

Feb 8, 2018

Actual Study Completion Date :

Feb 8, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Education Building	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

University of Iowa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Darren P Casey, Assistant Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT03459027

Other Study ID Numbers:

201708795

First Posted:

Mar 8, 2018

Last Update Posted:

Jan 9, 2019

Last Verified:

Jan 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Darren P Casey, Assistant Professor, University of Iowa

Additional relevant MeSH terms:

Hyperemia

Study Results

No Results Posted as of Jan 9, 2019