Clinical trial NCT05974813: The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness
Official title: The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: European University Cyprus
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 12
Sex: MALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* subject provides written informed consent.
* normal health profile.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in aortic and brachial systolic blood pressure (rest)
timeFrame: Change from baseline aortic and brachial systolic blood pressure at 7 days.
measure: Change in aortic and brachial systolic blood pressure
timeFrame: Change from baseline aortic and brachial systolic blood pressure at the second minute of exercise.
measure: Change in carotid-femoral pulse wave velocity (cfPWV) (rest)
timeFrame: Change from baseline aortic and brachial systolic blood pressure at 7 days.
Secondary outcomes:
measure: Change in pulse pressure (rest)
timeFrame: Change from baseline pulse pressure at 7 days.
measure: Change in heart rate (rest)
timeFrame: Change from baseline heart rate at 7 days.
measure: Change in augmented pressure (rest)
timeFrame: Change from baseline augmented pressure at 7 days.
measure: Change in augmentation index (rest)
timeFrame: Change from baseline augmentation index at 7 days.
measure: Change in forward and backward wave pressure (rest)
timeFrame: Change from baseline forward and backward wave pressure at 7 days.
measure: Change in muscle oxyhemoglobin (rest)
timeFrame: Change from baseline oxyhemoglobin at 7 days.
measure: Change in pulse pressure (exercise)
timeFrame: Change from baseline pulse pressure at the second minute of exercise.
measure: Change in heart rate (exercise)
timeFrame: Change from baseline heart rate at the second minute of exercise.
measure: Change in augmented pressure (exercise)
timeFrame: Change from baseline augmented pressure at the second minute of exercise.
measure: Change in augmentation index (exercise)
timeFrame: Change from baseline augmentation index at the second minute of exercise.
measure: Change in forward and backward wave pressure (exercise)
timeFrame: Change from baseline forward and backward wave pressure at the second minute of exercise.
measure: Change in muscle deoxyhemoglobin (exercise)
timeFrame: Change from baseline muscle deoxyhemoglobin at the second minute of exercise.
measure: Change in muscle deoxyhemoglobin (rest)
timeFrame: Change from baseline muscle deoxyhemoglobin at 7 days.
measure: Change in muscle oxyhemoglobin (exercise)
timeFrame: Change from baseline muscle oxyhemoglobin at the second minute of exercise.
measure: Change in muscle oxyhemoglobin (rest)
timeFrame: Change from baseline muscle oxyhemoglobin at 7 days.
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: European University Cyprus
Study officials:
affiliation: European University Cyprus
name: Marios Vryonides, Dr.
role: STUDY_DIRECTOR
References: