跳至主要内容
临床试验/NCT02214290
NCT02214290已完成不适用

Effect of Oral Caffeine and L-Citrulline Supplementation on Arterial Function in Healthy Males

Florida State University0 个研究点目标入组 16 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
Aortic Blood Pressure

研究概览

简要总结

Caffeine is an exceedingly popular and consumed pharmacological agent. Although caffeine is primarily consumed from coffee and tea beverages, it is also available in other forms such as sodas, energy drinks, tablets and capsules. Nevertheless, caffeine acutely increases brachial and aortic systolic blood pressure (BP) and arterial stiffness. Arterial stiffness is an independent predictor of cardiovascular disease (CVD) and assessed through pulse wave velocity (PWV). Interestingly, previous studies have proposed that caffeine may increase aortic BP through increases in aortic PWV and augmentation index (AIx), a measurement of wave reflection. Yet, these effects were seen in middle-aged adults with treated hypertension and a wide age range. Therefore, it is imperative to consider that caffeine may cause different effects in young normotensive individuals than in older adults independently of BP levels. Importantly, oral supplementation of the amino-acid, L-citrulline has been shown to enhance the bioavailability of L-arginine levels and nitric oxide (NO) production and, therefore, improve arterial function. L-citrulline supplementation for 7 days given at 6 g/day has shown to increase NO levels while improving PWV. Previous studies by our group also demonstrated that L-citrulline supplementation reduces the BP response to cold exposure; a condition with an increased vasoconstriction. Therefore, the acute effects of caffeine on central and peripheral PWV and BP in healthy young men are yet to be fully evaluated. We hypothesized that acute caffeine intake would increase peripheral and aortic BP and PWV and that L-citrulline supplementation would attenuate the effects induced by acute caffeine ingestion.

详细描述

The specific aims of this study are:

AIM 1: To examine the effects of the acute ingestion of 200mg caffeine (tablets) on arterial function in young adults. The working hypothesis is that acute caffeine intake would increase brachial, ankle and aortic BP, PWV (aortic and leg), and wave reflection. In order to test this hypothesis, the investigators will perform non-invasive measurements of arterial stiffness (aortic and leg PWV) and pulse wave analysis (aortic BP and AIx) using applanation tonometry of the radial artery 30, 45, and 60 minutes following caffeine ingestion.

AIM 2: To determine the effectiveness of L-citrulline supplementation to attenuate the acute cardiovascular effects of caffeine ingestion. The working hypothesis is that 7 days of L-citrulline supplementation will attenuate the unfavorable arterial responses (increases in BP, PWV, and wave reflection) to acute caffeine ingestion. In order to test this hypothesis, the investigators will perform the same procedures previously specified in AIM 1.

Description of the study:

Sixteen healthy young men 18-40 years of age will be enrolled in this study. Participants with CVD history, resting BP (> 160/100 mmHg), recent history of smoking, or considered competitive athlete will be excluded from the study. All subjects will refrain from food and caffeine for > 8 hours and from exercise for > 24 hours before testing.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Young healthy males
  • Non smoker
  • Non endurance trained athlete
  • No previous history of cardiovascular disease

排除标准

  • Blood pressure greater than 160/100

研究组 & 干预措施

Caffeine

Active Comparator

200 mg caffeine tablet produced by CVS Pharmacy, USA

干预措施: Caffeine (Drug)

Placebo

Placebo Comparator

Placebo pill produced by NOW FOODS, USA

干预措施: Placebo (Drug)

L-citrulline

Experimental

L-citrulline capsule (750 mg) provided by NOW FOODS

干预措施: L-citrulline (Dietary Supplement)

结局指标

主要结局

Aortic Blood Pressure

时间窗: Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points)

Aortic blood pressure at rest and 30 minutes after acute ingestion of 200 mg of caffeine before and after 7 days of either 6g/day of Citrulline or 6 g/day of Placebo.

次要结局

  • Changes in Reflected Wave Pressure (P2)(Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points))
  • Changes in Femoral-ankle Pulse Wave Velocity After 7 Days of Either L-Citrulline or Placebo (6g/Day)(Baseline and Day 7 (Calculated change between rest and 30 minutes post-caffeine ingestion at these time points))

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

相似试验