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Study Title and Description

Cognitive and physiological effects of an "energy drink": an evaluation of the whole drink and of glucose, caffeine and herbal flavouring fractions.



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 Cognitive and physiological effects of an "energy drink": an evaluation of the whole drink and of glucose, caffeine and herbal flavouring fractions.
Author AB Scholey,DO Kennedy,
Country
Year 2004
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)? We assessed the mood, cognitive and physiological effects of a soft drink containing caffeine and glucose as well as flavouring levels of herbal extracts. The effects of different drink fractions were also evaluated.
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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) Participants Fourteen female and six male undergraduate volunteers (mean age 21.1 years, age range 18–32 years) took part in the study. All participants reported that they were in good health, and were taking no illicit social drugs. Additionally, they were free of any "over the counter" or prescribed medications, with the exception, for some female volunteers, of the contraceptive pill. Smokers were excluded from the study. All participants were overnight fasted and abstained from caffeine-containing products on the mornings of the study, and alcohol for a minimum of 12 h prior to the first testing session of study days. Physiological Measurements/Heart Rate Heart rates were measured using a N100-P hand-held pulse oximeter (Nellcor Puritan Bennet, Coventry, UK) according to the manufacturer’s instructions. Average heart rates were calculated over 60-s epochs. Treatments On each study day, participants received one of five 250 ml drinks. The individual drinks comprised: (1) vehicle, containing water as its major constituent, with artificial sweeteners and flavourings to produce a matched placebo, but no active ingredients; (2) vehicle plus 75 mg caffeine (derived from direct addition of caffeine plus guarana extract); (3) vehicle plus 37.5 g glucose; (4) vehicle plus flavouring levels of herbs (12.5 mg ginseng extract and 2.004 mg ginkgo biloba extract); and (5) the complete energy drink containing 75 mg caffeine, 37.5 g glucose and flavouring levels of herbs. Procedure Each participant was required to attend a total of 6 study days that were conducted 7 days apart. Visits were completed by 12 noon and each participant was tested at the same time on subsequent visits. During the first session on the first day, participants were allocated to a treatment regime using a Latin square design which counterbalanced the order of treatments across the 5 active days of the study. A person not involved in the trial carried out random allocation to treatment regimens manually using random number tables. The first day was identical to the following 5 days, with the exception that no treatment (active or placebo) was offered. This session allowed familiarisation with the test battery and procedure, and attenuation of any practice effects. Data from the practice day were not included in any analysis. On arrival at each session, participants completed the first "predose" mood and cognitive performance testing session, which established baseline performance for that day. This was followed by the first heart rate and blood glucose reading, after which participants were allowed up to 5 min to consume the day’s treatment (visits 2–6). Heart rate and blood glucose levels were again established 28 min after consumption of the drink. The second testing session began 30 min after consumption of the day’s treatment, and was again followed by the final heart rate and glucose level measurement (approximately 60 min post-dose). Statistics Change from baseline heart rate was analysed using a two factor (condition x post-dose measurement) repeated measures ANOVA, between the placebo condition and each of the four active conditions (complete drink, glucose fraction, herbal fraction, caffeine fraction).
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Heart rate
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List additional health endpoints (separately). 2
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List additional health endpoints (separately).3
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List additional health endpoints (separately).4
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List additional health endpoints (separately).5
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List additional health endpoints (separately).6
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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 Heart rates were measured using a N100-P hand-held pulse oximeter (Nellcor Puritan Bennet, Coventry, UK)
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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?
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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 (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 15549275
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What were the sources of funding? This work was funded by GlaxoSmithKline Consumer Healthcare R&D, Slough, UK.
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Results & Comparisons

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