Effect of L-Citrulline on Vascular Function

NCT ID: NCT03127917

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

Brief Summary

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The objective of this project is to determine the importance of peripheral vascular function on gait performance in older adults.

Detailed Description

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This project employed a placebo controlled, double-blind, crossover trial. Participants were randomized to oral L-citrulline (6 g/day) or placebo (maltodextrin) for 14 days, and switched to the other treatment for another 14 days after washout. Peripheral vascular function was assessed under conditions of rest, leg exercise, and cognitive engagement. Gait performance was assessed using clinical walking tests.

Conditions

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Citrulline Blood Flow Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind research study

Study Groups

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CitrullinePlacebo

Subjects allocated to the CitrullinePlacebo study arm received L-citrulline first, followed by placebo.

Group Type EXPERIMENTAL

L-citrulline

Intervention Type DIETARY_SUPPLEMENT

L-citrulline capsules given at 6 g/day

Placebo

Intervention Type OTHER

Maltodextrin capsules given as placebo

PlaceboCitrulline

Subjects allocated to the PlaceboCitrulline study arm received placebo first, followed by L-citrulline.

Group Type EXPERIMENTAL

L-citrulline

Intervention Type DIETARY_SUPPLEMENT

L-citrulline capsules given at 6 g/day

Placebo

Intervention Type OTHER

Maltodextrin capsules given as placebo

Interventions

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L-citrulline

L-citrulline capsules given at 6 g/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin capsules given as placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* older adults
* women and men
* aged 60-79 yrs
* must be able to swallow capsules
* fully mobile without assistive walking devices

Exclusion Criteria

* have physician diagnosed cardiovascular, pulmonary, or metabolic disease
* are current smokers
* currently taking medications affecting cardiovascular function
* have high blood pressure (\>159/99 mmHG)
* have high fasting blood glucose (\>110 mg/dL)
* are considered obese (body mass index ≥ 30 kg/m2)
* have orthopaedic limitations that limit walking ability
* have pacemaker or other metal objects in their body
Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Joaquin U Gonzales, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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15BGIA22710012

Identifier Type: -

Identifier Source: org_study_id

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