Effect of L-Citrulline on Vascular Function

May 1, 2018 updated by: Joaquin U Gonzales, PhD, Texas Tech University

Impact of Reduced Arterial Stiffness on Peripheral Vascular Function and Mobility

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CitrullinePlacebo
Subjects allocated to the CitrullinePlacebo study arm received L-citrulline first, followed by placebo.
Dietary supplement: L-citrulline
L-citrulline capsules given at 6 g/day
Other: Placebo
Maltodextrin capsules given as placebo
Experimental: PlaceboCitrulline
Subjects allocated to the PlaceboCitrulline study arm received placebo first, followed by L-citrulline.
Dietary supplement: L-citrulline
L-citrulline capsules given at 6 g/day
Other: Placebo
Maltodextrin capsules given as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Flow
Time Frame: baseline and 2 weeks for L-citrulline and placebo
Femoral blood flow during leg exercise and carotid blood flow during mental activity measured using Doppler ultrasound. Blood-oxygen-level dependent contrast imaging of the brain using functional magnetic resonance imaging (fMRI) during cognitive functioning.
baseline and 2 weeks for L-citrulline and placebo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Performance
Time Frame: baseline and 2 weeks for L-citrulline and placebo
Usual and fast walking speeds measured during short (7m) and long (400m) distances.
baseline and 2 weeks for L-citrulline and placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University

Collaborators

American Heart Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

March 22, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15BGIA22710012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Raw data for outcome variables will be made available on the online general repository "figshare" within 12 months of funding end date.

IPD Sharing Time Frame

Within 12 months of funding end date.

IPD Sharing Access Criteria

Use these two URL's to access different data sets and associated published work.

https://figshare.com/s/1b382cb5e788663047e7 https://figshare.com/s/c45b46f67391b140f774

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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