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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672447
• Other study ID #: 20-0152
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 27, 2022

Study information

• Verified date: October 2022
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Menopause

Intervention

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

Locations

Country	Name	City	State
United States	TTU Kinesiology and Sport Management Building	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	Kyowa Hakko Bio Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	L-Arginine bioavailability	Plasma levels of arginine will be measured before and after the 4 week intervention.	4 weeks
Secondary	cardiovascular hemodynamics using pulse wave analysis during the cold pressor test	arterial tonometry will be measured during the cold pressor test before and after the 4 week intervention.	4 weeks
Secondary	body composition	We will determine whether L-citrulline + glutathione changes body composition more than L-citrulline or placebo.	4 weeks
Secondary	Muscle Strength	Leg Extension strength will be measured before and after the 4 weeks.	4 weeks
Secondary	L-Citrulline levels	Plasma levels of L-Citrulline will be measured before and after the 4 weeks.	4 weeks
Secondary	Glutathione peroxidase levels	Blood levels of glutathione peroxidase will be measured before and after the 4 weeks	4 weeks
Secondary	Malondialdehyde	blood levels of malondialdehyde will be measured before and after the 4 weeks	4 weeks
Secondary	L-Ornithine levels	plasma levels of L-ornithine will be measured before and after the 4 weeks	4 weeks