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Completed

NCT Number: NCT03127917

Effect of L-Citrulline on Vascular Function

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

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Key information

Conditions

Citrulline Aging Blood Flow

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-citrulline

Dietary Supplement

L-citrulline capsules given at 6 g/day

Placebo

Other

Maltodextrin capsules given as placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Impact of Reduced Arterial Stiffness on Peripheral Vascular Function and Mobility

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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