Clinical trial NCT04672447: Effect of 4 Weeks of Citrulline and Glutathione Supplementation on Arterial Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Cardiovascular Risk Factor
Keywords: Endothelial Function
Aortic Hemodynamics
Pressure Wave Reflection
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Kyowa Hakko Bio Co., Ltd.
First posted: 2020-12-17
Enrollment: 39
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in endothelial function
timeFrame: 4 weeks
measure: Change in arterial stiffness
timeFrame: 4 weeks
measure: Blood pressure control during the cold pressor test
timeFrame: 4 weeks
measure: L-Arginine bioavailability
timeFrame: 4 weeks
Secondary outcomes:
measure: cardiovascular hemodynamics using pulse wave analysis during the cold pressor test
timeFrame: 4 weeks
measure: body composition
timeFrame: 4 weeks
measure: Muscle Strength
timeFrame: 4 weeks
measure: L-Citrulline levels
timeFrame: 4 weeks
measure: Glutathione peroxidase levels
timeFrame: 4 weeks
measure: Malondialdehyde
timeFrame: 4 weeks
measure: L-Ornithine levels
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: TTU Kinesiology and Sport Management Building
state: Texas
Study officials:
References: