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Study Title and Description

Double-blind placebo and active (caffeine) controlled study to examine the effects of the herbal nutritional supplement beverage "Wake up" on vigilance and function after lunch.



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 Double-blind placebo and active (caffeine) controlled study to examine the effects of the herbal nutritional supplement beverage "Wake up" on vigilance and function after lunch.
Author O Kassis,N Katz,S Ravid,G Pillar,
Country
Year 2013
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)? To assess whether a new herbal-based potentially wake-promoting beverage is effective in counteracting somnolence and reduced post-lunch performance.
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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) At the first study visit they were given an explanation about the study, signed the consent form, and were trained with the performance tests. Thereafter, the study consisted of three additional visits, with 6 +/- 3 days between each visit. At each visit, participants reported to the study room around noontime. They were given a similar and standardized lunch between 12:00 and 13:00, after which they drank one small bottle containing Wake up, 50 mg caffeine, or a placebo in a cross-over double-blind regimen. All three drinks had a similar look and taste (which were specifically prepared for this study by a flavor and fragrance-producing company), and were in a similar 100 ml bottle. Volunteers were asked to maintain a stable and regular schedule and a stable sleep/ wake regimen during the study period. They were also asked to consume a similar breakfast on the three mornings of the study visits. Each visit had the same routine: participants ate lunch and immediately drank 100 ml of beverage (Wake up, caffeine, or placebo). At 30 minutes and 120 minutes after drinking, they underwent a battery of tests including measurement of vital signs, blood pressure, immediate word recall test (short-term memory), digit symbol substitution test (concentration), and subjective rating (on a visual analogue scale) of their vigilance, ability to focus, and effectiveness at work.
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How many outcome-specific endpoints are evaluated? 2
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Pulse
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List additional health endpoints (separately). 2 Blood pressure (systolic and diastolic)
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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? NCT
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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 Not provided.
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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.) Placebo vs. 50 mg caffeine.
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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)
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What conflicts of interest were reported? None of the authors has stock or any other financial interest in the company.
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Refid 24079062
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What were the sources of funding? This study was supported by a non-restricted grant from C.O.L. Group, the manufacturer of "Wake up."
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Results & Comparisons

No Results found.