Effect of 4 Weeks of Citrulline and Glutathione Supplementation on Arterial Function

NCT ID: NCT04672447

Last Updated: 2022-10-20

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-04-27

Brief Summary

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Examining the effects of 4 weeks of Citrulline alone or in combination with glutathione on the arterial function of postmenopausal women.

Detailed Description

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L-Citrulline is a non-protein amino acid and an efficient precursor of L-arginine, the substrate for endothelial nitric oxide synthesis. Glutathione is a tripeptide with antioxidant effects. Postmenopausal women will ingest 6g/d of L-Citrulline or 2g of L-Citrulline plus 200mg/d of glutathione or placebo (maltodextrin) for 4 weeks with vascular function testing prior to and after the intervention.

Conditions

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Menopause Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Randomized, placebo-controlled, double-blind, parallel-groups study.

Study Groups

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L-Citrulline + Glutathione

Citrulline: 2 grams/day, Glutathione: 200mg/day for 4 weeks

Group Type EXPERIMENTAL

L-Citrulline

Intervention Type DIETARY_SUPPLEMENT

Four weeks of oral L-Citrulline (2 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Glutathione

Intervention Type DIETARY_SUPPLEMENT

Four weeks of Glutathione (200mg/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

L-Citrulline

Citrulline: 6 grams/day

Group Type EXPERIMENTAL

L-Citrulline

Intervention Type DIETARY_SUPPLEMENT

Four weeks of oral L-Citrulline (6 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Placebo

Maltodextrin: 6 grams/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Four weeks of oral placebo (6 grams/day maltodextrin) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Interventions

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L-Citrulline

Four weeks of oral L-Citrulline (2 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Intervention Type DIETARY_SUPPLEMENT

L-Citrulline

Four weeks of oral L-Citrulline (6 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Four weeks of oral placebo (6 grams/day maltodextrin) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Intervention Type DIETARY_SUPPLEMENT

Glutathione

Four weeks of Glutathione (200mg/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Generally healthy, postmenopausal women (defined as the absence of menstruation for at least 1 year).
2. Between the ages of 50-79 years.
3. Body mass index of 18.5 - 34.9 kg/m2.
4. Brachial systolic blood pressure \< 150 mmHg, and diastolic blood pressure \< 90 mmHg.
5. Sedentary (defined as \< 120 min/week of exercise).
6. Be willing and able to comfortably abstain from any of food supplements for the period of time beginning 1 month prior to the study to the time of the termination of the study.
7. Not participating as a subject in another study for at least 2 months prior to the study and for the duration of this study.

Exclusion Criteria

1. Current or prior use of tobacco products, e-cigarettes or other inhaled substance.
2. Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, but not limited to those.)
3. Taking hormone replacement therapy during the 3 months before the study.
4. More than a moderate intake of alcohol (\>7 drink per week).
5. Cardiovascular diseases, diabetes and other metabolic or chronic diseases.
6. Musculoskeletal disorders that will prevent exercise performance.
7. Currently taking more than one vasoactive drug for blood pressure control.

* Subject having no more than one drug for prevention, which does not affect variables, may be included, but will be diagnosed as not having a disease.
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kyowa Hakko Bio Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TTU Kinesiology and Sport Management Building

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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20-0152

Identifier Type: -

Identifier Source: org_study_id

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