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Study Title and Description

Sensitivity of the Finometer device in detecting acute and medium-term changes in cardiovascular function.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on cardiovascular outcomes?
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Primary Publication Information
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TitleData
Title Sensitivity of the Finometer device in detecting acute and medium-term changes in cardiovascular function.
Author AE Schutte,HW Huisman,JM Van Rooyen,W Oosthuizen,JC Jerling,
Country
Year 2003
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Cardiovascular Design
Design Details
Question... Follow Up Answer Follow-up Answer
What outcome is being evaluated in this paper? Cardiovascular
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What is the objective of the study (as reported by the authors)? The aim of this study was to determine the sensitivity of the Finometer regarding acute and longer term cardiovascular changes.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) The participants of the study consisted of 38 apparently healthy normotensive Caucasian male volunteers, between the ages of 18 and 25 years. Exclusion criteria were hypertensive subjects and drinking more than five cups of coffee (300mg) per day. Any vitamin supplementation that the subjects may normally use was discontinued for at least 2 weeks before the study was performed. Subjects were not permitted to drink any caffeine-containing drinks on the evening prior to the study. Experimental Design The first part that dealt with the acute effect of caffeine was a double-blind, placebo-controlled crossover intervention study which used all 38 subjects. [NOTE: The second part of the study is not relevant.] Subjects were admitted overnight to a metabolic ward facility. Each participant was subjected to the experimental procedures on two occasions, with the second occasion occurring 1 week after the first. Experimental Procedure Subjects reported the metabolic ward facility at 1800 h, where they were all introduced to the experimental set-up and Finometer apparatus. Body mass and height measurements were taken and all subjects provided answers to a general health questionnaire. They received a light meal, excluding caffeine-containing food and drinks, and went to sleep before 2300 h. All Finometer recordings were performed from 0600 h the next morning, after the overnight fast. Intervention The subject was awake and lying in the Fowler’s position in a quiet single bedroom while the resting Finometer recording was performed. Subjects were not permitted to walk around or have anything to eat or drink until all recordings were finished. Each subject in turn was connected to the device and blood pressure was recorded continuously for a period of at least 10min. Blood pressure was regarded as resting when the systolic blood pressure did not change with more than 10mmHg during the last minute of this period, otherwise the resting period was extended with a maximum of 3 min. After the Finometer recording was taken the subjects were randomized into two groups who took either a 200mg caffeine or placebo capsule with a glass of water. After a period of 30 min the Finometer apparatus was used again to obtain at least a 10-min recording. Computation of Cardiovascular Data The Finometer device computed all cardiovascular variables online and stored the data in results files on a hard disk. The Beatscope 1.1 software program (Finapres Measurement Systems, Arnhem, Netherlands) integrates the subject’s gender, age, body mass and height, and it was used to obtain the following cardiovascular variables: systolic and diastolic blood pressure, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance and arterial compliance Statistical Analysis All processed data was transferred to Microsoft Excel and further statistically analysed by means of the software computer package Statistica. Dependent t –tests were performed to obtain statistically significant (P <0.05) differences between the baseline cardiovascular values and the values after intake of caffeine, or baseline values and the values after intake of placebo. Independent t -tests were used to determine whether significant differences (P <0.05) existed between the cardiovascular values of the experimental and control groups.
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How many outcome-specific endpoints are evaluated? 6
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Blood pressure (SBP, DBP, MAP)
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List additional health endpoints (separately). 2 Heart rate
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List additional health endpoints (separately).3 Stroke volume
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List additional health endpoints (separately).4 Cardiac output
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List additional health endpoints (separately).5 Total peripheral resistance
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List additional health endpoints (separately).6 Arterial compliance (Windkessel)
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Clinical, physiological, other Physiological
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What is the study design? Controlled Trial
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Randomized or Non-Randomized? RCT
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What were the diagnostics or methods used to measure the outcome? Objective
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Optional: Name of Method or short description The Finometer device computed all cardiovascular variables
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Caffeine (general) Caffeine (general)
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Coffee, Chocolate, energy drink, gum, medicine/supplement, soda, tea, other?
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Measured or self reported? Measured
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Children, adolescents, adults, or pregnant included? Adults
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Subjects served as their own controls (baseline and placebo)
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) None
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What conflicts of interest were reported? No information provided
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Refid 14624169
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What were the sources of funding? We are also grateful to the Government’s Technology and Human Resources for Industry Programme (THRIP) and the Potchefstroom University for CHE for funding.
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