Blood PressureNCT05974813
The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness
A study testing L-Citrulline in people with Blood Pressure, run by European University Cyprus at 1 site in Cyprus.
Trial summary
The goal of this clinical trial is to examine the effect of short-term L-Citrulline on central and peripheral blood pressure in healthy older adults. The main questions it aims to answer are: Does L-citrulline favorably affect blood pressure at rest and during exercise? Does L-citrulline favorably affect arterial… Read more about this study
- Who is it for?
- Ages 55 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- L-Citrulline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jan 2023to 1 Mar 2023
- 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 55 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject provides written informed consent.
- normal health profile.
Who cannot join
- history of musculoskeletal injury in the legs during the previous six months.
- smoker.
- consumption of any medication the last three months.
- consumption of any nutritional supplement the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to examine the effect of short-term L-Citrulline on central and peripheral blood pressure in healthy older adults. The main questions it aims to answer are:
- Does L-citrulline favorably affect blood pressure at rest and during exercise?
- Does L-citrulline favorably affect arterial stiffness?
- Does L-citrulline favorably affect muscle oxygenation at rest and during exercise?
Read more
Participants will be asked to consume L-citrulline and a placebo for six days and participate in the evaluation of their blood pressure, arterial stiffness, and muscle oxygenation before and after each intervention.
Researchers will compare L-citrulline and placebo groups to examine whether L-citrulline supplementation affects the above health parameters.
- Conditions
- Blood Pressure
- Being tested
- L-Citrulline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CitrullineDietary supplement
6 g (3 g every 12 h) of L-citrulline for six days
PlaceboDietary supplement
6 g (3 g every 12 h) of maltodextrin for six days
| Study group | Role | What they receive |
|---|---|---|
| L-Citrulline | Experimental | Participants will receive 6 g (3 g every 12 h) of L-citrulline (Now, L-citrulline Pure Powder) for six-days. Receives: Dietary Supplement: L-Citrulline |
| Placebo | Placebo comparator | Participants will receive 6 g (3 g every 12 h) of maltodextrin (Now, Maltodextrin) for six-days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aortic and brachial systolic blood pressure (rest)
Measured: Change from baseline aortic and brachial systolic blood pressure at 7 days.
Change in aortic and brachial systolic blood pressure
Measured: Change from baseline aortic and brachial systolic blood pressure at the second minute of exercise.
Change in carotid-femoral pulse wave velocity (cfPWV) (rest)
Measured: Change from baseline aortic and brachial systolic blood pressure at 7 days.
Secondary outcomes (15)
Change in pulse pressure (rest)
Measured: Change from baseline pulse pressure at 7 days.
Change in heart rate (rest)
Measured: Change from baseline heart rate at 7 days.
Change in augmented pressure (rest)
Measured: Change from baseline augmented pressure at 7 days.
Change in augmentation index (rest)
Measured: Change from baseline augmentation index at 7 days.
Change in forward and backward wave pressure (rest)
Measured: Change from baseline forward and backward wave pressure at 7 days.
Change in muscle oxyhemoglobin (rest)
Measured: Change from baseline oxyhemoglobin at 7 days.
Change in pulse pressure (exercise)
Measured: Change from baseline pulse pressure at the second minute of exercise.
Change in heart rate (exercise)
Measured: Change from baseline heart rate at the second minute of exercise.
Change in augmented pressure (exercise)
Measured: Change from baseline augmented pressure at the second minute of exercise.
Change in augmentation index (exercise)
The ideal augmentation index is between 20 and 80. Values above 80 are considered high, and above 121 indicate high arterial stiffness.
Measured: Change from baseline augmentation index at the second minute of exercise.
Change in forward and backward wave pressure (exercise)
Measured: Change from baseline forward and backward wave pressure at the second minute of exercise.
Change in muscle deoxyhemoglobin (exercise)
Measured: Change from baseline muscle deoxyhemoglobin at the second minute of exercise.
Change in muscle deoxyhemoglobin (rest)
Measured: Change from baseline muscle deoxyhemoglobin at 7 days.
Change in muscle oxyhemoglobin (exercise)
Measured: Change from baseline muscle oxyhemoglobin at the second minute of exercise.
Change in muscle oxyhemoglobin (rest)
Measured: Change from baseline muscle oxyhemoglobin at 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Jan 2023
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anastasios Theodorou, European University Cyprus
- Investigators
- Marios Vryonides, Dr., Study director, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974813
- Sponsor's protocol ID
- EUC_cit
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness
- ClinicalTrials.gov ID
- NCT05974813
- Acronym / sponsor ID
- EUC_cit
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 3 Aug 2023 (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 goal of this clinical trial is to examine the effect of short-term L-Citrulline on central and peripheral blood pressure in healthy older adults. The main questions it aims to answer are:
- Does L-citrulline favorably affect blood pressure at rest and during exercise?
- Does L-citrulline favorably affect arterial stiffness?
- Does L-citrulline favorably affect muscle oxygenation at rest and during exercise?
Participants will be asked to consume L-citrulline and a placebo for six days and participate in the evaluation of their blood pressure, arterial stiffness, and muscle oxygenation before and after each intervention.
Researchers will compare L-citrulline and placebo groups to examine whether L-citrulline supplementation affects the above health parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-Citrulline | Experimental | Dietary Supplement: L-CitrullineParticipants will receive 6 g (3 g every 12 h) of L-citrulline (Now, L-citrulline Pure Powder) for six-days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive 6 g (3 g every 12 h) of maltodextrin (Now, Maltodextrin) for six-days. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject provides written informed consent.
- normal health profile.
Key exclusion criteria (4 listed)
- history of musculoskeletal injury in the legs during the previous six months.
- smoker.
- consumption of any medication the last three months.
- consumption of any nutritional supplement the last three months.
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-Citrulline6 g (3 g every 12 h) of L-citrulline for six days | Dietary supplement | L-Citrulline |
| Placebo6 g (3 g every 12 h) of maltodextrin for six days | Dietary supplement | Placebo |
Primary outcome
Change in aortic and brachial systolic blood pressure (rest)
Time frame: Change from baseline aortic and brachial systolic blood pressure at 7 days.
Change in aortic and brachial systolic blood pressure
Time frame: Change from baseline aortic and brachial systolic blood pressure at the second minute of exercise.
Change in carotid-femoral pulse wave velocity (cfPWV) (rest)
Time frame: Change from baseline aortic and brachial systolic blood pressure at 7 days.
15 secondary outcomes
Change in pulse pressure (rest)
Time frame: Change from baseline pulse pressure at 7 days.
Change in heart rate (rest)
Time frame: Change from baseline heart rate at 7 days.
Change in augmented pressure (rest)
Time frame: Change from baseline augmented pressure at 7 days.
Change in augmentation index (rest)
Time frame: Change from baseline augmentation index at 7 days.
Change in forward and backward wave pressure (rest)
Time frame: Change from baseline forward and backward wave pressure at 7 days.
Change in muscle oxyhemoglobin (rest)
Time frame: Change from baseline oxyhemoglobin at 7 days.
Change in pulse pressure (exercise)
Time frame: Change from baseline pulse pressure at the second minute of exercise.
Change in heart rate (exercise)
Time frame: Change from baseline heart rate at the second minute of exercise.
Change in augmented pressure (exercise)
Time frame: Change from baseline augmented pressure at the second minute of exercise.
Change in augmentation index (exercise)
Time frame: Change from baseline augmentation index at the second minute of exercise.
Change in forward and backward wave pressure (exercise)
Time frame: Change from baseline forward and backward wave pressure at the second minute of exercise.
Change in muscle deoxyhemoglobin (exercise)
Time frame: Change from baseline muscle deoxyhemoglobin at the second minute of exercise.
Change in muscle deoxyhemoglobin (rest)
Time frame: Change from baseline muscle deoxyhemoglobin at 7 days.
Change in muscle oxyhemoglobin (exercise)
Time frame: Change from baseline muscle oxyhemoglobin at the second minute of exercise.
Change in muscle oxyhemoglobin (rest)
Time frame: Change from baseline muscle oxyhemoglobin at 7 days.
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 3 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Marios Vryonides, Dr. study director
European University Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Citrulline in people with Blood Pressure, run by European University Cyprus at 1 site in Cyprus.
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 2 inclusion and 4 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in aortic and brachial systolic blood pressure (rest) (time frame: Change from baseline aortic and brachial systolic blood pressure at 7 days.). The study lists 3 primary outcomes in all. 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 3 Aug 2023.