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

Texas Tech University

Status: Completed

Conditions: Menopause; Cardiovascular Risk Factor

Treatments: Dietary Supplement: L-Citrulline; Dietary Supplement: Placebo; Dietary Supplement: Glutathione

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04672447

20-0152

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 50 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups, including a placebo group

L-Citrulline + Glutathione

Experimental group

Description:

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

Treatment:

Dietary Supplement: L-Citrulline

Dietary Supplement: L-Citrulline

Dietary Supplement: Glutathione

L-Citrulline

Experimental group

Description:

Citrulline: 6 grams/day

Treatment:

Dietary Supplement: L-Citrulline

Dietary Supplement: L-Citrulline

Placebo

Placebo Comparator group

Description:

Maltodextrin: 6 grams/day

Treatment:

Dietary Supplement: Placebo