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Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women

L-Citrulline Supplementation to Improve Vascular Function and Responsiveness at Rest and During Exercise in Postmenopausal Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05600413
Enrollment
26
Registered
2022-10-31
Start date
2020-07-07
Completion date
2022-04-27
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Endothelial function, Blood pressure, Blood flow

Brief summary

The objective of this project is to provide evidence that L-Citrulline (L-CIT) supplementation can improve vascular function at rest and in response to exercise in postmenopausal women.

Detailed description

L-CIT is a non-essential amino acid that is a precursor to L-arginine, the substrate used to produce an important vasodilatory molecule called nitric oxide. The purpose of this study is to identify the effects of 6 grams of L-CIT for 4 weeks on vascular function (endothelial function, blood flow, muscle oxygenation, and blood pressure) at rest and in response to different stressors (cold pressor test, isometric and dynamic exercise).

Interventions

DIETARY_SUPPLEMENTL-Citrulline

4 weeks of L-Citrulline supplementation (6 grams/day)

DIETARY_SUPPLEMENTPlacebo

4 weeks of Placebo (crystalline cellulose)

Sponsors

Texas Tech University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

* Postmenopausal (absence of menstruation \> 1 year) between the ages of 50 - 79 years. * Sedentary ( \< 120 minutes of exercise/week) * Resting systolic blood pressure \< 150 mmHg and diastolic blood pressure \< 90 mmHg * Not participating as a subject in another study for at least 2 months prior to the study and for the duration of the study * Willingness to abstain from food supplements 1 month prior to the start of the study and throughout the duration of the study

Exclusion criteria

* Body mass index ≥ 40 * Currently taking more than one vasoactive drug for blood pressure control * Cardiometabolic diseases or other chronic diseases * Taking hormone replacement therapy 3 months prior to the study * Current or prior use of tobacco products * More than a moderate intake of alcohol * Use of medications and/or supplements that may affect outcome variables * Musculoskeletal disorders that will prevent exercise performance

Design outcomes

Primary

MeasureTime frameDescription
Muscle oxygenation during dynamic exercise4 weeksMuscle oxygenation will be measured using near infrared spectroscopy during dynamic exercises superimposed with the cold pressor test.
Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during metaboreflex activation4 weeksBrachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff during isometric handgrip exercise and postexercise muscle ischemia.
Changes in aortic hemodynamics using pulse wave analysis during metaboreflex activation4 weeksThe speed and reflection pressures, both representing aortic hemodynamic parameters, will be assessed using radial applanation tonometry and a validated transfer function (AtCor Medical) during isometric handgrip exercise and postexercise muscle ischemia.
Blood flow during dynamic exercise4 weeksBlood flow will be measured using ultrasound in the superficial femoral and brachial artery during dynamic exercises superimposed with the cold pressor test.
Microvascular endothelial function4 weeksEndothelial function will be assessed via reactive hyperemic index using the EndoPAT device.

Secondary

MeasureTime frameDescription
Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during dynamic plantarflexion exercise and handgrip combined with the cold pressor test4 weeksBrachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff during dynamic plantarflexion exercise and handgrip combined with the cold pressor test.
Changes in aortic hemodynamics using pulse wave analysis during dynamic plantarflexion exercise and handgrip combined with the cold pressor test4 weeksThe speed and reflection pressures, both representing aortic hemodynamic parameters, will be assessed using radial applanation tonometry and a validated transfer function (AtCor Medical) during dynamic plantarflexion exercise and handgrip combined with the cold pressor test.
Serum nitric oxide levels4 weeksSerum levels of nitric oxide will be assessed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026