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Study Title and Description

Effects of coffee consumption on subclinical inflammation and other risk factors for type 2 diabetes: a clinical trial.



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 Effects of coffee consumption on subclinical inflammation and other risk factors for type 2 diabetes: a clinical trial.
Author K Kempf,C Herder,I Erlund,H Kolb,S Martin,M Carstensen,W Koenig,J Sundvall,S Bidel,S Kuha,J Tuomilehto,
Country
Year 2010
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 was to investigate the effects of daily coffee consumption on biomarkers of coffee intake, subclinical inflammation, oxidative stress, glucose, and lipid metabolism.
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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) Study design: The study represents a single-blind (investigator), 3-stage clinical trial (number of clinical trial: ISRCTN12547806) that lasted for 3 mo. Subjects received 0, 3, or 5 packages with 500 g coffee/mo. Juhla Mokka branded coffee was provided by the Paulig Group (Helsinki, Finland). Coffee was prepared with participants’ coffee machines at home. The subjects brewed the coffee daily at home with their own coffee machine using paper filters. They were allowed to divide their daily coffee dose as it suited them best and to keep the brewed coffee in a thermos if it was impossible to prepare it freshly before drinking. During the first month, participants refrained from drinking coffee, whereas in the second month they consumed 4 cups coffee/d (1 cup = 150 mL) and in the third month 8 cups/d. Serum concentrations of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were measured by using enzymatic assays on a Hitachi 912 analyzer (Roche Diagnostics, Mannheim, Germany). Serum concentrations of apolipoproteins A-I and B were assessed by immunonephelometric assays on a BN II analyzer (Dade Behring, Marburg, Germany).
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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) Cholesterol
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List additional health endpoints (separately). 2 Apolipoprotein
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List additional health endpoints (separately).3 Triglycerides
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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 Serum concentrations of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were measured by using enzymatic assays on a Hitachi 912 analyzer (Roche Diagnostics, Mannheim, Germany). Serum concentrations of apolipoproteins A-I and B were assessed by immunonephelometric assays on a BN II analyzer (Dade Behring, Marburg, Germany).
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Caffeine (general)
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Coffee, Chocolate, energy drink, gum, medicine/supplement, soda, tea, other? Coffee
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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.) Coffee drinkers abstained for one month (baseline) then had measurements (cholesterol) taken. There was no placebo group.
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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) The results are expressed as means 6 SDs or median and interquartile ranges as specified. Differences in the concentrations of coffee-derived compounds or immune mediators (8 compared with 0 cups/d and 4 compared with 0 cups/d) were analyzed by Friedman’s test and Dunn’s multiple comparisons test (adjusted for the number of post-tests; ie, n = 2 for comparisons of 8 compared with 0 and 4 compared with 0 cups of coffee/d for each variable). Analyses were done for the whole study groups (primary analysis) and for predefined subgroups (study group subdivided by median of fasting insulin concentrations and homeostasis model assessment of insulin resistance (HOMA-IR; exploratory analyses). Associations between changes in coffee-derived compounds and test variable levels were assessed with Spearman correlation coefficients.
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What conflicts of interest were reported? The authors’ responsibilities were as follows—KK: analyzed the data and wrote the manuscript; CH: contributed to the study design and data analysis, performed research, and revised the manuscript; HK: contributed to the study design and data analysis and revised the manuscript; SM: contributed to the study design and revised the manuscript; MC, WK, and JS: performed research and revised the manuscript; SB: contributed to the study design and data analysis, performed research, and revised the manuscript; IE: contributed to the study design, conducted the nutritional biomarker analyses, and wrote the part of the manuscript concerning the nutritional biomarkers; SK: contributed to the study design, organized the clinical trial, performed the research, and reviewed the manuscript; and JT: contributed to the study design and data analysis, performed research, and revised the manuscript. JT has given lectures about the health effects of coffee and received travel grants and compensation for it. None of the other authors declared a conflict of interest.
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Refid 20181814
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What were the sources of funding? Not mentioned.
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Results & Comparisons

No Results found.