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Completed

NCT Number: NCT04672447

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

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

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Key information

Age range

50 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TTU Kinesiology and Sport Management Building

Lubbock, Texas, 79409, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in endothelial function

    Time frame: 4 weeks

    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.

  2. Change in arterial stiffness

    Time frame: 4 weeks

    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.

  3. Blood pressure control during the cold pressor test

    Time frame: 4 weeks

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

  4. L-Arginine bioavailability

    Time frame: 4 weeks

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

Secondary outcomes

  1. cardiovascular hemodynamics using pulse wave analysis during the cold pressor test

    Time frame: 4 weeks

    arterial tonometry will be measured during the cold pressor test before and after the 4 week intervention.

  2. body composition

    Time frame: 4 weeks

    We will determine whether L-citrulline + glutathione changes body composition more than L-citrulline or placebo.

  3. Muscle Strength

    Time frame: 4 weeks

    Leg Extension strength will be measured before and after the 4 weeks.

  4. L-Citrulline levels

    Time frame: 4 weeks

    Plasma levels of L-Citrulline will be measured before and after the 4 weeks.

  5. Glutathione peroxidase levels

    Time frame: 4 weeks

    Blood levels of glutathione peroxidase will be measured before and after the 4 weeks

  6. Malondialdehyde

    Time frame: 4 weeks

    blood levels of malondialdehyde will be measured before and after the 4 weeks

  7. L-Ornithine levels

    Time frame: 4 weeks

    plasma levels of L-ornithine will be measured before and after the 4 weeks

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • Kyowa Hakko Bio Co., Ltd.

Registry information

Official study title

Effects of 4 Weeks Supplementation With L-Citrulline and Glutathione on Arterial Function and Cardiovascular Responses in Postmenopausal Healthy Women: A Pilot Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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