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临床试验/NCT02143817
NCT02143817已完成不适用

The Effect of Whole-body Vibration Training Combined With L-cit Supplementation on Cardiovascular, Autonomic Function and Body Composition in Postmenopausal Women

Florida State University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Blood Pressure

研究概览

简要总结

Arterial dysfunction contributes to the development of cardiovascular disease (CVD), which is currently afflicting millions of individuals. The use of the amino acid L-citrulline has been suggested as a potential aid for the treatment of CVD by increasing endothelial production of Nitric Oxide (NO). Whole body vibration (WBV) is new and effective form of exercise that is feasible for clinical populations and has been proven to decrease blood pressure (BP) and arterial stiffness and increase muscle mass and strength. Therefore, the purpose of this study was to investigate if the combination of WBV training (WBVT) plus L-citrulline supplementation would induce positive additive effects and would be an effective means to ameliorate arterial stiffness, endothelial function, BP and muscle strength/mass in postmenopausal women.

详细描述

The purpose of this study is to investigate the effects of 8 weeks combination of WBVT plus L-citrulline supplementation on arterial stiffness, endothelial function, BP and muscle strength/mass in overweight/obese postmenopausal women.

The specific aims of the study are:

  1. To investigate if the additive effect of 8 weeks of WBVT combined with L-citrulline supplementation are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx], 6-keto PGFIa, insulin, and ghrelin) and vasoconstrictors (endothelin-1 [ET-1],8-iso PGF2a,vascular endothelium growth factor [VGEF]) will be assessed as secondary outcome variables.
  2. To evaluate the extent to which 8 weeks of WBVT combined with L-citrulline improves body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.
  3. To determine the additive effect of 8 weeks of WBVT combined with L-citrulline supplementation on muscle strength. These will be evaluated using the eight-repetition maximum test for the leg press and chest press exercises

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)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female 50 to 70 years of age At least 1 year after menopause Body mass index of 27-39.9 Sedentary or low active (less than 2 hr per wk)

排除标准

  • Younger than 50 or older than 70 years of age Body mass index lower than 27, or 40 or higher Physically active or competitively active Smoker Use of hormone replacement therapy of less than 1 yr Use of calcium channel blocker or beta blockers Use dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants) Uncontrolled diabetes Any restriction that would significantly interfere with compliance with the L-citrulline supplementation

结局指标

主要结局

Blood Pressure

时间窗: 8 weeks

Non-invasive measures of brachial and aortic blood pressure

Arterial Stiffness and pressure wave reflection

时间窗: 8 weeks

Using pulse wave velocity of the aorta, systemic, and legs and the augmentation index from radial tonometry

Endothelial and autonomic functions

时间窗: 8 weeks

By measuring circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NOx, 6-keto PGFIa, insulin, and ghrelin)and vasoconstrictors (ET-1 and 8-iso PGF2a, VEGF).In addition, heart rate variability, vascular sympathetic activity \[low-frequency power of systolic BP variability\], and spontaneous baroreflex sensitivity will be assessed from electrocardiogram and beat-by-beat digital blood pressure.

次要结局

  • Body Composition(8 weeks)
  • Muscle Strength(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arturo Figueroa

Associate Professor

Florida State University

研究点 (2)

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