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临床试验/NCT03127917
NCT03127917已完成不适用

Impact of Reduced Arterial Stiffness on Peripheral Vascular Function and Mobility

Texas Tech University0 个研究点目标入组 25 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
主要终点
Blood Flow

研究概览

简要总结

The objective of this project is to determine the importance of peripheral vascular function on gait performance in older adults.

详细描述

This project employed a placebo controlled, double-blind, crossover trial. Participants were randomized to oral L-citrulline (6 g/day) or placebo (maltodextrin) for 14 days, and switched to the other treatment for another 14 days after washout. Peripheral vascular function was assessed under conditions of rest, leg exercise, and cognitive engagement. Gait performance was assessed using clinical walking tests.

研究设计

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

盲法说明

Double-blind research study

入排标准

年龄范围
60 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •older adults
  • •women and men
  • •aged 60-79 yrs
  • •must be able to swallow capsules
  • •fully mobile without assistive walking devices

排除标准

  • •have physician diagnosed cardiovascular, pulmonary, or metabolic disease
  • •are current smokers
  • •currently taking medications affecting cardiovascular function
  • •have high blood pressure (>159/99 mmHG)
  • •have high fasting blood glucose (>110 mg/dL)
  • •are considered obese (body mass index ≥ 30 kg/m2)
  • •have orthopaedic limitations that limit walking ability
  • •have pacemaker or other metal objects in their body

研究组 & 干预措施

CitrullinePlacebo

Experimental

Subjects allocated to the CitrullinePlacebo study arm received L-citrulline first, followed by placebo.

干预措施: Placebo (Other)

PlaceboCitrulline

Experimental

Subjects allocated to the PlaceboCitrulline study arm received placebo first, followed by L-citrulline.

干预措施: Placebo (Other)

PlaceboCitrulline

Experimental

Subjects allocated to the PlaceboCitrulline study arm received placebo first, followed by L-citrulline.

干预措施: L-citrulline (Dietary Supplement)

CitrullinePlacebo

Experimental

Subjects allocated to the CitrullinePlacebo study arm received L-citrulline first, followed by placebo.

干预措施: L-citrulline (Dietary Supplement)

结局指标

主要结局

Blood Flow

时间窗: baseline and 2 weeks for L-citrulline and placebo

Femoral blood flow during leg exercise and carotid blood flow during mental activity measured using Doppler ultrasound. Blood-oxygen-level dependent contrast imaging of the brain using functional magnetic resonance imaging (fMRI) during cognitive functioning.

次要结局

  • Gait Performance(baseline and 2 weeks for L-citrulline and placebo)

研究者

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

Joaquin U Gonzales, PhD

Associate Professor

Texas Tech University

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Effect of L-Citrulline on Vascular Function | 临床试验