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

Sponsor
European University Cyprus (Other)
Overall Status
Completed
CT.gov ID
NCT05974813
Collaborator
(none)
12
1
2
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6.2

Study Details

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
  • Dietary Supplement: L-Citrulline
  • Dietary Supplement: Placebo
N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2023
Actual Primary Completion Date :
Mar 1, 2023
Actual Study Completion Date :
Mar 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) [Change from baseline aortic and brachial systolic blood pressure at 7 days.]

  2. Change in aortic and brachial systolic blood pressure [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) [Change from baseline aortic and brachial systolic blood pressure at 7 days.]

Secondary Outcome Measures

  1. Change in pulse pressure (rest) [Change from baseline pulse pressure at 7 days.]

  2. Change in heart rate (rest) [Change from baseline heart rate at 7 days.]

  3. Change in augmented pressure (rest) [Change from baseline augmented pressure at 7 days.]

  4. Change in augmentation index (rest) [Change from baseline augmentation index at 7 days.]

  5. Change in forward and backward wave pressure (rest) [Change from baseline forward and backward wave pressure at 7 days.]

  6. Change in muscle oxyhemoglobin (rest) [Change from baseline oxyhemoglobin at 7 days.]

  7. Change in pulse pressure (exercise) [Change from baseline pulse pressure at the second minute of exercise.]

  8. Change in heart rate (exercise) [Change from baseline heart rate at the second minute of exercise.]

  9. Change in augmented pressure (exercise) [Change from baseline augmented pressure at the second minute of exercise.]

  10. Change in augmentation index (exercise) [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) [Change from baseline forward and backward wave pressure at the second minute of exercise.]

  12. Change in muscle deoxyhemoglobin (exercise) [Change from baseline muscle deoxyhemoglobin at the second minute of exercise.]

  13. Change in muscle deoxyhemoglobin (rest) [Change from baseline muscle deoxyhemoglobin at 7 days.]

  14. Change in muscle oxyhemoglobin (exercise) [Change from baseline muscle oxyhemoglobin at the second minute of exercise.]

  15. Change in muscle oxyhemoglobin (rest) [Change from baseline muscle oxyhemoglobin at 7 days.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 European University Cyprus Nicosia Cyprus 1516

Sponsors and Collaborators

  • European University Cyprus

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Anastasios Theodorou, Associate Professor, European University Cyprus
ClinicalTrials.gov Identifier:
NCT05974813
Other Study ID Numbers:
  • EUC_cit
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 3, 2023