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Study Title and Description

Effect of a thermogenic beverage on 24-hour energy metabolism in humans.



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 Effect of a thermogenic beverage on 24-hour energy metabolism in humans.
Author S Rudelle,MG Ferruzzi,I Cristiani,J Moulin,K Macé,KJ Acheson,L Tappy,
Country
Year 2007
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 the present study was to investigate the effect of consuming three servings per day of a beverage containing a mixture of green tea extract, caffeine, and calcium, ingredients that have individually been demonstrated to increase energy expenditure (EE) and lipid oxidation and decrease fat mass in human volunteers, on 24-hour EE, substrate use, and markers of sympathetic nervous stimulation in a group of young, healthy, normal-weight men and women.
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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 present study was a double-blind, placebo-controlled, single-center, randomized cross-over clinical trial. Subjects Male and female subjects were recruited by advertisement posted on the Medical School notice boards. Interested individuals visited the Physiology Department, University of Lausanne. Potential volunteers were given a medical check-up (brief medical history and physical examination including measurements of blood pressure and heart rate). Thirty-two non-smoking, moderately active, healthy, young subjects between 18 and 35 years, with a BMI between 20 and 25 kg/m2, consuming <5 cups of coffee or tea per day, were selected to participate in the study. Experimental Design Each subject was studied on three occasions. Period 1: The first occasion was to collect patient anthropometric data and assess basal metabolic rate (BMR) and body composition. Subjects presented at the Physiology Department in the morning, after an overnight fast. Participants were then randomized to the two possible sequences of beverage intake, A-B or B-A (Periods 2 and 3), with sex used as a stratification factor. Periods 2 and 3: Each period lasted 3 days, during which the subject’s energy requirements, calculated from measured BMR, were provided by the Physiology Department’s dietitian. The subjects maintained a low, sedentary physical activity and did not take any medication in this period. During the first 2 days, the subject was free-living and consumed 1.6 x 24-hour BMR energy. He/she was instructed on how to prepare the easy-to-prepare meals and to consume only the diet provided (food and test beverages and water ad libitum). On the 3rd day, the subject was confined to an indirect calorimeter chamber, where his/her energy metabolism was measured continuously for 23 hours, and his/her diet (energy equivalent to 1.4 x 24-hour BMR) was provided. The menus and meals consumed during Period 2 were repeated exactly, meal for meal and day for day, during Period 3 with the exception that the beverage was changed. Periods 2 and 3 were separated by at least 21 days so that women could be studied in the follicular phase of their cycle. Beverage Composition The test beverage and placebo were blinded at the production site and were distinguishable to the investigators and subjects only by the label Formula A or Formula B. The green tea extract was cold water soluble and was prepared from a green tea powdered extract (Choladi TCTG; Nestle´ Co., Choladi, India) containing catechins and caffeine naturally in levels similar to a standard tea profile. After batch analysis, chemically synthesized caffeine was added to bring the dose to 100 mg caffeine/serving. Calcium was added because the lactate salt and Fibersol-2 (Matsutani Chemical Industry Co., Itami City, Japan) provided the soluble fiber. The placebo beverage contained 3 grams of fibersol-2 and natural colorants to obtain visual aspects similar to the test beverage. The beverages were served cold (approx. 6°C) and were consumed within 20 min at 9:30 AM, 3 PM, and 8 PM each day. Metabolic Measurements The subject arrived at the Physiology Institute at 7:30 AM, and an investigator confirmed that the subject had followed instructions and filled out the compliance questionnaire. After voiding and recording body weight, the subject was equipped with a sphygmomanometer (-2430 Ambulatory Blood Pressure Monitoring System; A&D Company, Ltd., Tokyo, Japan) for automatic blood pressure and heart rate measurement during the 23 hours in the chamber (every 15 minutes during the day and every 2 hours during the night). The subject entered the metabolic chamber at 8 AM and remained in the chamber until 7 AM the next morning. While in the chamber, the subject was occupied with sedentary activities such as watching television, listening to music, reading, etc. However, on two occasions, from 11 AM to 11:30 AM and from 4:30 PM to 5 PM, light exercise (50 watts for 30 minutes) was performed on a bicycle ergometer. Lights were turned off at 11 PM, and the subject was allowed to sleep until just before 7 AM, when he/she exited the chamber. Continuous respiratory exchange measurements were made for 23 hours, withvalues being printed and electronically stored every 15 minutes. Total urine was collected as two-timed collections from approx. 8 AM to approx. 11 PM and from approx. 11 PM to approx. 7 AM for measurement of urinary urea nitrogen and catecholamine concentrations. Aliquots of the urine samples were acidified with 6 N HCl (0.1 mL/10 mL) and stored at approx. 20°C until catecholamine analysis using high-performance liquid chromatography with electrochemical detection. Data Management and Analysis Raw data from each subject’s case report form was entered into a Clintrial database (Clintrial 4.3; Phase Forward, Waltham, MA) with double entry. Electronic data from the 23-hour respiratory exchange and blood pressure recordings, made in the calorimeter chamber, were extracted from Microsoft Excel worksheets (Microsoft, Redmond, WA), extrapolated to 24 hours, and entered into the Clintrial database for calculations and data reporting. Statistical Analysis Thirty-two subjects were recruited; however, one subject took non-prescribed medication before the first 3-day test period. Consequently, only 31 subjects were studied in the metabolic chamber, and the protocol results are presented. All parameters were analyzed using Student’s paired t test to assess the effect of the treatment vs. placebo beverage. SAS software (version 8.02; SAS Institute Inc., Cary, NC) was used. Values are expressed as mean +/- SE, unless stated otherwise, and p values < 0.05 were considered significant.
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How many outcome-specific endpoints are evaluated? 3
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Blood pressure (SBP and DBP)
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List additional health endpoints (separately). 2 Heart rate
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List additional health endpoints (separately).3 Urinary catecholamines (epinephrine and norepinephrine
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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 Blood pressure and heart rate were collected with a sphygmomanometer (-2430 Ambulatory Blood Pressure Monitoring System; A&D Company, Ltd., Tokyo, Japan). Urinary catecholamine concentrations measured using high-performance liquid chromatography with electrochemical detection.
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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 controls
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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 17299107
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What were the sources of funding? This study was supported by a grant from Nestle´ SA, Vevey, Switzerland.
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Results & Comparisons

No Results found.