跳至主要内容
临床试验/NCT04672447
NCT04672447已完成不适用

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

Texas Tech University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Blood pressure control during the cold pressor test

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

Randomized, placebo-controlled, double-blind, parallel-groups study.

入排标准

年龄范围
50 Years 至 79 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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/m
  • 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.

排除标准

  • 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.

结局指标

主要结局

Blood pressure control during the cold pressor test

时间窗: 4 weeks

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

Change in endothelial function

时间窗: 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.

Change in arterial stiffness

时间窗: 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.

L-Arginine bioavailability

时间窗: 4 weeks

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

次要结局

  • L-Citrulline levels(4 weeks)
  • Glutathione peroxidase levels(4 weeks)
  • Muscle Strength(4 weeks)
  • Malondialdehyde(4 weeks)
  • L-Ornithine levels(4 weeks)
  • cardiovascular hemodynamics using pulse wave analysis during the cold pressor test(4 weeks)
  • body composition(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验