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

• ClinicalTrials.gov Identifier: NCT05974813
• Recruitment Status: Completed
• First Posted: August 3, 2023
• Last Update Posted: August 3, 2023
• Sponsor: European University Cyprus
• Information provided by (Responsible Party): Dr. Anastasios Theodorou, European University Cyprus

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Blood Pressure	Dietary Supplement: L-Citrulline; Dietary Supplement: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness
• Actual Study Start Date: January 1, 2023
• Actual Primary Completion Date: March 1, 2023
• Actual Study Completion Date: March 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: L-Citrulline; Participants will receive 6 g (3 g every 12 h) of L-citrulline (Now, L-citrulline Pure Powder) for six-days.	Dietary Supplement: L-Citrulline; 6 g (3 g every 12 h) of L-citrulline for six days
Placebo Comparator: Placebo; Participants will receive 6 g (3 g every 12 h) of maltodextrin (Now, Maltodextrin) for six-days.	Dietary Supplement: Placebo; 6 g (3 g every 12 h) of maltodextrin for six days

Outcome Measures

Primary Outcome Measures :

1. Change in aortic and brachial systolic blood pressure (rest) [ Time Frame: Change from baseline aortic and brachial systolic blood pressure at 7 days. ]
2. 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. ]
3. Change in carotid-femoral pulse wave velocity (cfPWV) (rest) [ Time Frame: Change from baseline aortic and brachial systolic blood pressure at 7 days. ]

Secondary Outcome Measures :

1. Change in pulse pressure (rest) [ Time Frame: Change from baseline pulse pressure at 7 days. ]
2. Change in heart rate (rest) [ Time Frame: Change from baseline heart rate at 7 days. ]
3. Change in augmented pressure (rest) [ Time Frame: Change from baseline augmented pressure at 7 days. ]
4. Change in augmentation index (rest) [ Time Frame: Change from baseline augmentation index at 7 days. ]
5. Change in forward and backward wave pressure (rest) [ Time Frame: Change from baseline forward and backward wave pressure at 7 days. ]
6. Change in muscle oxyhemoglobin (rest) [ Time Frame: Change from baseline oxyhemoglobin at 7 days. ]
7. Change in pulse pressure (exercise) [ Time Frame: Change from baseline pulse pressure at the second minute of exercise. ]
8. Change in heart rate (exercise) [ Time Frame: Change from baseline heart rate at the second minute of exercise. ]
9. Change in augmented pressure (exercise) [ Time Frame: Change from baseline augmented pressure at the second minute of exercise. ]
10. Change in augmentation index (exercise) [ Time Frame: Change from baseline augmentation index at the second minute of exercise. ]
    The ideal augmentation index is between 20 and 80. Values above 80 are considered high, and above 121 indicate high arterial stiffness.
11. Change in forward and backward wave pressure (exercise) [ Time Frame: Change from baseline forward and backward wave pressure at the second minute of exercise. ]
12. Change in muscle deoxyhemoglobin (exercise) [ Time Frame: Change from baseline muscle deoxyhemoglobin at the second minute of exercise. ]
13. Change in muscle deoxyhemoglobin (rest) [ Time Frame: Change from baseline muscle deoxyhemoglobin at 7 days. ]
14. Change in muscle oxyhemoglobin (exercise) [ Time Frame: Change from baseline muscle oxyhemoglobin at the second minute of exercise. ]
15. Change in muscle oxyhemoglobin (rest) [ Time Frame: Change from baseline muscle oxyhemoglobin at 7 days. ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Cyprus

European University Cyprus

Nicosia, Cyprus, 1516

Sponsors and Collaborators

European University Cyprus

Investigators

• Study Director: Marios Vryonides, Dr.; European University Cyprus

More Information

• Responsible Party: Dr. Anastasios Theodorou, Associate Professor, European University Cyprus
• ClinicalTrials.gov Identifier: NCT05974813
• Other Study ID Numbers: EUC_cit
• First Posted: August 3, 2023
• Last Update Posted: August 3, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No