Clinical trial NCT05600413: Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women
Official title: L-Citrulline Supplementation to Improve Vascular Function and Responsiveness at Rest and During Exercise in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Endothelial function
Blood pressure
Blood flow
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 26
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Microvascular endothelial function
timeFrame: 4 weeks
measure: Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during metaboreflex activation
timeFrame: 4 weeks
measure: Changes in aortic hemodynamics using pulse wave analysis during metaboreflex activation
timeFrame: 4 weeks
measure: Blood flow during dynamic exercise
timeFrame: 4 weeks
measure: Muscle oxygenation during dynamic exercise
timeFrame: 4 weeks
Secondary outcomes:
measure: Serum nitric oxide levels
timeFrame: 4 weeks
measure: Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during dynamic plantarflexion exercise and handgrip combined with the cold pressor test
timeFrame: 4 weeks
measure: Changes in aortic hemodynamics using pulse wave analysis during dynamic plantarflexion exercise and handgrip combined with the cold pressor test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: Texas Tech University
name: Arturo Figueroa
role: PRINCIPAL_INVESTIGATOR
References: