CitrullineNCT03127917
Effect of L-Citrulline on Vascular Function
A study testing L-citrulline in people with Citrulline and Blood Flow, run by Texas Tech University.
Trial summary
The objective of this project is to determine the importance of peripheral vascular function on gait performance in older adults. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Citrulline, Blood Flow, Aging
- What is being tested?
- L-citrulline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older adults
- women and men
- aged 60-79 yrs
- must be able to swallow capsules
- fully mobile without assistive walking devices
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Citrulline, Blood Flow, Aging
- Being tested
- L-citrulline, Placebo
- Keywords
- Gait Speed, Cognitive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-citrullineDietary supplement
L-citrulline capsules given at 6 g/day
PlaceboOther
Maltodextrin capsules given as placebo
| Study group | Role | What they receive |
|---|---|---|
| CitrullinePlacebo | Experimental | Subjects allocated to the CitrullinePlacebo study arm received L-citrulline first, followed by placebo. Receives: Dietary Supplement: L-citrulline; Other: Placebo |
| PlaceboCitrulline | Experimental | Subjects allocated to the PlaceboCitrulline study arm received placebo first, followed by L-citrulline. Receives: Dietary Supplement: L-citrulline; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 2 weeks for L-citrulline and placebo
Secondary outcomes (1)
Gait Performance
Usual and fast walking speeds measured during short (7m) and long (400m) distances.
Measured: baseline and 2 weeks for L-citrulline and placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startJul 2015
- Primary completion22 Mar 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CitrullineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Joaquin U Gonzales, PhD, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127917
- Sponsor's protocol ID
- 15BGIA22710012
- Status last verified
- May 2018
- First submitted
- 20 Apr 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data for outcome variables will be made available on the online general repository "figshare" within 12 months of funding end date.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reduced Arterial Stiffness on Peripheral Vascular Function and Mobility
- ClinicalTrials.gov ID
- NCT03127917
- Acronym / sponsor ID
- 15BGIA22710012
- Conditions
- Citrulline, Blood Flow, Aging
- Keywords
- Gait Speed, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2015 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to determine the importance of peripheral vascular function on gait performance in older adults.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CitrullinePlacebo | Experimental | Dietary Supplement: L-citrulline, Other: PlaceboSubjects allocated to the CitrullinePlacebo study arm received L-citrulline first, followed by placebo. |
| PlaceboCitrulline | Experimental | Dietary Supplement: L-citrulline, Other: PlaceboSubjects allocated to the PlaceboCitrulline study arm received placebo first, followed by L-citrulline. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- older adults
- women and men
- aged 60-79 yrs
- must be able to swallow capsules
- fully mobile without assistive walking devices
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-citrullineL-citrulline capsules given at 6 g/day | Dietary supplement | CitrullinePlacebo, PlaceboCitrulline |
| PlaceboMaltodextrin capsules given as placebo | Other | CitrullinePlacebo, PlaceboCitrulline |
Primary outcome
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.
1 secondary outcome
Gait Performance
Time frame: baseline and 2 weeks for L-citrulline and placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: Yes. Raw data for outcome variables will be made available on the online general repository "figshare" within 12 months of funding end date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing L-citrulline in people with Citrulline and Blood Flow, run by Texas Tech University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Flow (time frame: baseline and 2 weeks for L-citrulline and placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.