Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women

NCT05600413 | Completed

• 1 other identifier: IRB2019-1197
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Endothelial function; Blood pressure; Blood flow

Outcome Measures

Primary Outcomes (5)

• Microvascular endothelial function

  Endothelial function will be assessed via reactive hyperemic index using the EndoPAT device.

  4 weeks

• 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

• 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

• 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

• 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 Outcomes (3)

• Serum nitric oxide levels

  4 weeks

• Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during dynamic plantarflexion exercise and handgrip combined with the cold pressor test

  4 weeks

• Changes in aortic hemodynamics using pulse wave analysis during dynamic plantarflexion exercise and handgrip combined with the cold pressor test

  4 weeks

Study Arms (2)

L-Citrulline

EXPERIMENTAL

L-Citrulline: 6 grams/day

Dietary Supplement: L-Citrulline

Placebo

PLACEBO COMPARATOR

Crystalline Cellulose

Dietary Supplement: Placebo

Interventions

L-Citrulline DIETARY_SUPPLEMENT

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

L-Citrulline

Placebo DIETARY_SUPPLEMENT

4 weeks of Placebo (crystalline cellulose)

Placebo

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

MeSH Terms

Interventions

Citrulline

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Arturo Figueroa

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arturo Figueroa, Principal Investigator

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

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 31, 2022
• Study Start: July 7, 2020
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)