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Completed

NCT Number: NCT05974813

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

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.

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Key information

Conditions

Blood Pressure

Age range

55 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

European University Cyprus

Nicosia, 1516, Cyprus

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-citrulline

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

European University Cyprus

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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