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

NCT04672447 | Completed

• 1 other identifier: 20-0152
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menopause; Cardiovascular Risk Factor

Keywords

Endothelial Function; Aortic Hemodynamics; Pressure Wave Reflection

Outcome Measures

Primary Outcomes (4)

• Change in endothelial function

  Endothelial function will be measured before and after the intervention using brachial artery flow mediated dilation at rest, blood flow measured in the brachial artery during handgrip exercise, and blood flow in the common femoral artery during passive leg movement. All measurements performed using doppler ultrasound.

  4 weeks

• Change in arterial stiffness

  Arterial stiffness will be assessed through measurement of pulse-wave velocity of the carotid-femoral, carotid radial, carotid-ankle and femoral ankle arterial segments before and after the 4 week interventions.

  4 weeks

• Blood pressure control during the cold pressor test

  Blood pressure will be measured during the cold pressor test before and after the 4 weeks.

  4 weeks

• L-Arginine bioavailability

  Plasma levels of arginine will be measured before and after the 4 week intervention.

  4 weeks

Secondary Outcomes (7)

• cardiovascular hemodynamics using pulse wave analysis during the cold pressor test

  4 weeks

• body composition

  4 weeks

• Muscle Strength

  4 weeks

• L-Citrulline levels

  4 weeks

• Glutathione peroxidase levels

  4 weeks

Study Arms (3)

L-Citrulline + Glutathione

EXPERIMENTAL

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

Dietary Supplement: L-Citrulline; Dietary Supplement: Glutathione

L-Citrulline

EXPERIMENTAL

Citrulline: 6 grams/day

Dietary Supplement: L-Citrulline

Placebo

PLACEBO COMPARATOR

Maltodextrin: 6 grams/day

Dietary Supplement: Placebo

Interventions

L-Citrulline 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.

L-Citrulline + Glutathione

Placebo 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.

Placebo

Glutathione 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 + Glutathione

Eligibility Criteria

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

You may qualify if:

• Generally healthy, postmenopausal women (defined as the absence of menstruation for at least 1 year).
• Between the ages of 50-79 years.
• Body mass index of 18.5 - 34.9 kg/m2.
• Brachial systolic blood pressure \< 150 mmHg, and diastolic blood pressure \< 90 mmHg.
• Sedentary (defined as \< 120 min/week of exercise).
• 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.
• Not participating as a subject in another study for at least 2 months prior to the study and for the duration of this study.

You may not qualify if:

• Current or prior use of tobacco products, e-cigarettes or other inhaled substance.
• 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.)
• Taking hormone replacement therapy during the 3 months before the study.
• More than a moderate intake of alcohol (\>7 drink per week).
• Cardiovascular diseases, diabetes and other metabolic or chronic diseases.
• Musculoskeletal disorders that will prevent exercise performance.
• 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.

Sponsors & Collaborators

• Texas Tech University: lead
• Kyowa Hakko Bio Co., Ltd.: collaborator

Study Sites (1)

TTU Kinesiology and Sport Management Building

Lubbock, Texas, 79409, United States

Location

MeSH Terms

Interventions

Citrulline; Glutathione

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized, placebo-controlled, double-blind, parallel-groups study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: July 1, 2020
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (1)