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Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women

NCT ID: NCT05600413

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2022-04-27

Brief Summary

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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

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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).

Conditions

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Menopause

Keywords

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Endothelial function Blood pressure Blood flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-Citrulline

L-Citrulline: 6 grams/day

Group Type EXPERIMENTAL

L-Citrulline

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Crystalline Cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

4 weeks of Placebo (crystalline cellulose)

Interventions

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L-Citrulline

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

4 weeks of Placebo (crystalline cellulose)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Arturo Figueroa

Arturo Figueroa, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arturo Figueroa

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

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Texas Tech University

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB2019-1197

Identifier Type: -

Identifier Source: org_study_id