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Effect of L-Citrulline on Vascular Function

Sponsor
Texas Tech University (Other)
Overall Status
Completed
CT.gov ID
NCT03127917
Collaborator
American Heart Association (Other)
25
Enrollment
2
Arms
30
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: L-citrulline
  • Other: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind research study
Primary Purpose:
Other
Official Title:
Impact of Reduced Arterial Stiffness on Peripheral Vascular Function and Mobility
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Mar 22, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Blood Flow [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.

Secondary Outcome Measures

  1. Gait Performance [baseline and 2 weeks for L-citrulline and placebo]

    Usual and fast walking speeds measured during short (7m) and long (400m) distances.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Texas Tech University
  • American Heart Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joaquin U Gonzales, PhD, Associate Professor, Texas Tech University
ClinicalTrials.gov Identifier:
NCT03127917
Other Study ID Numbers:
  • 15BGIA22710012
First Posted:
Apr 25, 2017
Last Update Posted:
May 4, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joaquin U Gonzales, PhD, Associate Professor, Texas Tech University
Gait Speed
Cognitive Function

Study Results

No Results Posted as of May 4, 2018