Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600413
• Other study ID #: IRB2019-1197
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: April 27, 2022

Study information

• Verified date: October 2022
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• L-Citrulline
4 weeks of L-Citrulline supplementation (6 grams/day)
• Placebo
4 weeks of Placebo (crystalline cellulose)

Locations

Country	Name	City	State
United States	Texas Tech University	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular endothelial function	Endothelial function will be assessed via reactive hyperemic index using the EndoPAT device.	4 weeks
Primary	Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during metaboreflex activation	Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff during isometric handgrip exercise and postexercise muscle ischemia.	4 weeks
Primary	Changes in aortic hemodynamics using pulse wave analysis during metaboreflex activation	The 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.	4 weeks
Primary	Blood flow during dynamic exercise	Blood flow will be measured using ultrasound in the superficial femoral and brachial artery during dynamic exercises superimposed with the cold pressor test.	4 weeks
Primary	Muscle oxygenation during dynamic exercise	Muscle oxygenation will be measured using near infrared spectroscopy during dynamic exercises superimposed with the cold pressor test.	4 weeks
Secondary	Serum nitric oxide levels	Serum levels of nitric oxide will be assessed.	4 weeks
Secondary	Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during dynamic plantarflexion exercise and handgrip combined with the cold pressor test	Brachial 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.	4 weeks
Secondary	Changes in aortic hemodynamics using pulse wave analysis during dynamic plantarflexion exercise and handgrip combined with the cold pressor test	The 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.	4 weeks