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

NCT05974813 | Completed DMC

• 1 other identifier: EUC_cit
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (3)

• Change in aortic and brachial systolic blood pressure (rest)

  Change from baseline aortic and brachial systolic blood pressure at 7 days.

• Change in aortic and brachial systolic blood pressure

  Change from baseline aortic and brachial systolic blood pressure at the second minute of exercise.

• Change in carotid-femoral pulse wave velocity (cfPWV) (rest)

  Change from baseline aortic and brachial systolic blood pressure at 7 days.

Secondary Outcomes (15)

• Change in pulse pressure (rest)

  Change from baseline pulse pressure at 7 days.

• Change in heart rate (rest)

  Change from baseline heart rate at 7 days.

• Change in augmented pressure (rest)

  Change from baseline augmented pressure at 7 days.

• Change in augmentation index (rest)

  Change from baseline augmentation index at 7 days.

• Change in forward and backward wave pressure (rest)

  Change from baseline forward and backward wave pressure at 7 days.

Study Arms (2)

L-Citrulline

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants will receive 6 g (3 g every 12 h) of maltodextrin (Now, Maltodextrin) for six-days.

Dietary Supplement: Placebo

Interventions

L-Citrulline DIETARY_SUPPLEMENT

6 g (3 g every 12 h) of L-citrulline for six days

L-Citrulline

Placebo DIETARY_SUPPLEMENT

6 g (3 g every 12 h) of maltodextrin for six days

Placebo

Eligibility Criteria

• Age: 55 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University Cyprus: lead

Study Sites (1)

European University Cyprus

Nicosia, 1516, Cyprus

Location

MeSH Terms

Interventions

Citrulline

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Marios Vryonides, Dr.

  European University Cyprus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 3, 2023
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)