The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness

Blood Pressure Clinical Trial

Official title:

The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05974813
• Other study ID #: EUC_cit
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 1, 2023

Study information

• Verified date: July 2023
• Source: European University Cyprus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Dietary Supplement:
• L-Citrulline
6 g (3 g every 12 h) of L-citrulline for six days
• Placebo
6 g (3 g every 12 h) of maltodextrin for six days

Locations

Country	Name	City	State
Cyprus	European University Cyprus	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
European University Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in aortic and brachial systolic blood pressure (rest)		Change from baseline aortic and brachial systolic blood pressure at 7 days.
Primary	Change in aortic and brachial systolic blood pressure		Change from baseline aortic and brachial systolic blood pressure at the second minute of exercise.
Primary	Change in carotid-femoral pulse wave velocity (cfPWV) (rest)		Change from baseline aortic and brachial systolic blood pressure at 7 days.
Secondary	Change in pulse pressure (rest)		Change from baseline pulse pressure at 7 days.
Secondary	Change in heart rate (rest)		Change from baseline heart rate at 7 days.
Secondary	Change in augmented pressure (rest)		Change from baseline augmented pressure at 7 days.
Secondary	Change in augmentation index (rest)		Change from baseline augmentation index at 7 days.
Secondary	Change in forward and backward wave pressure (rest)		Change from baseline forward and backward wave pressure at 7 days.
Secondary	Change in muscle oxyhemoglobin (rest)		Change from baseline oxyhemoglobin at 7 days.
Secondary	Change in pulse pressure (exercise)		Change from baseline pulse pressure at the second minute of exercise.
Secondary	Change in heart rate (exercise)		Change from baseline heart rate at the second minute of exercise.
Secondary	Change in augmented pressure (exercise)		Change from baseline augmented pressure at the second minute of exercise.
Secondary	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.	Change from baseline augmentation index at the second minute of exercise.
Secondary	Change in forward and backward wave pressure (exercise)		Change from baseline forward and backward wave pressure at the second minute of exercise.
Secondary	Change in muscle deoxyhemoglobin (exercise)		Change from baseline muscle deoxyhemoglobin at the second minute of exercise.
Secondary	Change in muscle deoxyhemoglobin (rest)		Change from baseline muscle deoxyhemoglobin at 7 days.
Secondary	Change in muscle oxyhemoglobin (exercise)		Change from baseline muscle oxyhemoglobin at the second minute of exercise.
Secondary	Change in muscle oxyhemoglobin (rest)		Change from baseline muscle oxyhemoglobin at 7 days.