Effect of L-Citrulline on Vascular Function

NCT03127917 | Completed

• 1 other identifier: 15BGIA22710012
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Citrulline; Blood Flow; Aging

Keywords

Gait Speed; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Blood Flow

  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 Outcomes (1)

• Gait Performance

  baseline and 2 weeks for L-citrulline and placebo

Study Arms (2)

CitrullinePlacebo

EXPERIMENTAL

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

Dietary Supplement: L-citrulline; Other: Placebo

PlaceboCitrulline

EXPERIMENTAL

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

Dietary Supplement: L-citrulline; Other: Placebo

Interventions

L-citrulline DIETARY_SUPPLEMENT

L-citrulline capsules given at 6 g/day

CitrullinePlacebo; PlaceboCitrulline

Placebo OTHER

Maltodextrin capsules given as placebo

CitrullinePlacebo; PlaceboCitrulline

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University: lead
• American Heart Association: collaborator

MeSH Terms

Interventions

Citrulline

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind research study
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: July 1, 2015
• Primary Completion: March 22, 2017
• Study Completion: December 31, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 12 months of funding end date.
• 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