Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001064291
Ethics application status
Approved
Date submitted
1/12/2009
Date registered
11/12/2009
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of filtered coffee intake in healthy subjects.
Scientific title
Effect of filtered coffee intake on biomarkers of the oxidative stress and of the inflammation in healthy volunteers
Secondary ID [1] 1188 0
None
Universal Trial Number (UTN)
U1111-1112-6149
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
risk reduction of cardiovascular disease 252277 0
risk reduction of Diabetes mellitus 252278 0
atherogenesis prevention 252279 0
Antioxidant activity of the coffee phenolic acids 252280 0
Condition category
Condition code
Cardiovascular 252461 252461 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 252462 252462 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty health volunteers, with age between 20 and 65 years old, will be selected and undergo 28 days of washout before the start the treatment. Then they will be divided in two groups: one will ingest from 3 to 4 cups daily (100 mL each one for people over 60 years old and 150 mL for people under 60 years old) of coffee brew with light roasting and another with dark roasting for 4 weeks. After, will be made a cross-over and the volunteers will ingest the coffee brew for over 4 weeks. Coffee will be provided to participants in daily portion. There will not have a washout between the two coffee groups, because studies show that phenolic acids bioavailability is short (After 4 hours of coffee intake, phenolic acid are not present in plasma in detectable amount), therefore 4 weeks are sufficient to eliminate the effect of one rosting on the other).
Intervention code [1] 241598 0
Prevention
Intervention code [2] 241599 0
Lifestyle
Comparator / control treatment
Treatment studied: coffee brew with light roasting and coffee brew with dark roasting. There will no have a control group, because each volunteer will be its own control
Control group
Active

Outcomes
Primary outcome [1] 253369 0
Total phenolic compounds in plasma. For this determination, plasma proteins will be precipitated and phenolic compounds quantified by Folin-ciocalteau method.
Timepoint [1] 253369 0
In the beginning of the intervention, after 4 weeks and after 8 weeks of intervention.
Primary outcome [2] 253370 0
Phenolic acids in plasma. To determine and quantify these acids, will be selected other 6 healthy volunteers, who will ingest 200mL of coffee beverage in a single dose.
Timepoint [2] 253370 0
The blood will be collected before the coffee ingestion and after 30min, 1h, 2h, 3h and 4h after coffee consumption.
Primary outcome [3] 253371 0
Oxidized Low density lipoprotein (LDL) in plasma. Quantification of ox-LDL in plasma will be performed by sandwich enzyme-linked immunosorbent assay (ELISA) (Mercodia AB, Uppsala, Sweden).
Timepoint [3] 253371 0
oxidized LDL will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Primary outcome [4] 253372 0
Inhibition of lipid peroxidation, verified by conjugated diene formation and by malonaldehyde quantification in High performance liquid chromatography (HPLC).
Timepoint [4] 253372 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Primary outcome [5] 253373 0
Evaluation of the antioxidant enzymes (catalase, glutathione peroxidase, and superoxide dismutase) activity. Catalase activity will be determined in erithrocytes, using the method described by AEBI H (Catalase in vitro. Methods
Enzymol. 1984; 105:121-6). Glutathione peroxidase and superoxide dismutase activity will be determined by RANSEL and RANSOD kit (Randox Lab, San Diego, CA), respectively
Timepoint [5] 253373 0
Antioxidant enzymes activity will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Primary outcome [6] 253374 0
Reduction of inflammatory biomarkers (fibrinogen, C-reactive protein, Interleukin 6 (IL-6), Interleukin 1b (IL-1b), soluble Intercellular adhesion molecule-1 (sICAM-1), soluble Vascular cell adhesion
molecule-1 (sVCAM-1), soluble E-selectin (sE-selectin), Adiponectin, Monocyte chemotactic protein-1 (MCP-1), Tumor necrosis factor-alpha (TNF-a) and Plasminogen activator inhibitor -1 (PAI-1). These biomarkers will be determined by panels for cardiovascular disease (LINCO Research, Inc.), using the Luminex xMAP technology.
Timepoint [6] 253374 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Primary outcome [7] 253375 0
Total homocysteine in plasma, quantified in High performance liquid chromatography (HPLC).
Timepoint [7] 253375 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Primary outcome [8] 253376 0
Improvement of insulin sensitivity and blood glucose stabilization. Fasting and postprandial blood glucose and insulin will be determined by commercial kit.
Timepoint [8] 253376 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Primary outcome [9] 253377 0
Blood pressure will be measured by "Arterial blood pressure ambulatorial Monitoring"
Timepoint [9] 253377 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [1] 262450 0
Nutritional status (weight, height, abdominal circunference and body fat percentage, measured by bioimpedance).
Timepoint [1] 262450 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [2] 262451 0
Hematocrit will be determined in whole blood by an automated machine.
Timepoint [2] 262451 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [3] 262452 0
Hemoglobin and glycated hemoglobin quantification. Hemoglobin will be quantified by commercial kit (Labtest) and this result will be used for enzymes antioxidant activity calculation. Glycated hemoglobin will be quantified to glycemic control monitoring in long term. This test provides an accurate indication of the average plasma glucose concentration within 2 to 3 months before testing, complementing the more traditional measures of glucose control,
as a measure of glucose in plasma or urine. For this determination, turbidimetric assay using a commercial kit and automated machine will be used.
Timepoint [3] 262452 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [4] 262453 0
Leukocytes (basophils, monocytes, white blood cell count and neutrophils) values will be determined in the hemogram (whole blood) by an automated electronic counter with two main sensors: a light detector and an electrical impedance.
Timepoint [4] 262453 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [5] 262454 0
Platelet aggregation test and coagulation time. The speed and extent to which platelets dispersed in a plasma sample form settlements after the addition of a material that stimulates the aggregation will be measured in a machine that measures the changes in turbidity "opacity" and print a graphic record of results.
Timepoint [5] 262454 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [6] 262455 0
Urea and creatinine are routine tests and they are important parameters to evaluate renal function. Biochemical testing of urea and creatinine will be performed in whole blood by using commercial kits (colorimetric method) in an automated machine.
Timepoint [6] 262455 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [7] 262456 0
Variation in sodium, potassium, magnesium, phosphorus and folate concentration will be dosed in the serum by an ion-selective electrode method.
Timepoint [7] 262456 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [8] 262457 0
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) values will be determined by commercial kits in an automated machine
Timepoint [8] 262457 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.
Secondary outcome [9] 262458 0
Total cholesterol, triacylglycerols, High density lipoprotein (HDL-c) and Very low density lipoprotein (VLDL-c) will be quantified in serum by enzymatic-colorimetric automated method, using commercial kits. Low density lipoprotein (LDL-c) will be calculated by Friedewald equation.
Timepoint [9] 262458 0
It will be determined in the beginning of the intervention period and after 4 and 8 weeks of intervention.

Eligibility
Key inclusion criteria
All races, non-smokers or former-smokers for more than 2 years, non-alcoholics, serum cholesterol below 240 mg/dL, fasting glucose below 100 mg/dL, normal liver enzymes (Aspartate aminotransferase - AST and Alanine aminotransferase - ALT) and normal plasma homocysteine, absence of continuous medicine intake. No history of cardivascular, kidney or liver disease, diabetes mellitus, hypertension or hyperthyroidism.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoker or former-smoker for less than 2 years, alcoholic, serum cholesterol above 240 mg/dL, fasting glucose above 100mg/dL, altered liver enzymes, and normal plasma homocysteine; medication intake daily; presence or development of cardiovascular, kidney or liver disease, diabetes mellitus, hypertension or hyperthyroidism.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created bu a computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
23/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2338 0
Brazil
State/province [1] 2338 0
Sao Paulo/ SP

Funding & Sponsors
Funding source category [1] 256100 0
Charities/Societies/Foundations
Name [1] 256100 0
Fundacao de Amparo a Pesquisa do Estado de S?o Paulo - FAPESP
Country [1] 256100 0
Brazil
Primary sponsor type
University
Name
University of Sao Paulo (USP) - School of Public Health
Address
Av. Dr. Arnaldo, 715 - Cerqueira Cesar
01246-904 - Sao Paulo/SP
Country
Brazil
Secondary sponsor category [1] 251446 0
Hospital
Name [1] 251446 0
Heart Institute (InCor), University of Sao Paulo, Medical School
Address [1] 251446 0
Av. Dr. Eneas de Carvalho Aguiar, 44 - 05403-900 - Sao Paulo/SP
Country [1] 251446 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258187 0
Ethics Committee of Public Halth School
Ethics committee address [1] 258187 0
Ethics committee country [1] 258187 0
Brazil
Date submitted for ethics approval [1] 258187 0
17/04/2009
Approval date [1] 258187 0
24/04/2009
Ethics approval number [1] 258187 0
OF.COEP/115/09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30546 0
Address 30546 0
Country 30546 0
Phone 30546 0
Fax 30546 0
Email 30546 0
Contact person for public queries
Name 13793 0
Elizabeth Aparecida Ferraz da Silva Torres
Address 13793 0
University of Sao Paulo USP
School of Public Health
Av. Dr. Arnaldo, 715 Cerqueira Cesar
01246-904 Sao Paulo SP BRAZIL
Country 13793 0
Brazil
Phone 13793 0
55 11 30617857
Fax 13793 0
Email 13793 0
[email protected]
Contact person for scientific queries
Name 4721 0
Telma Angelina Faraldo Correa
Address 4721 0
University of Sao Paulo USP
School of Public Health
Av. Dr. Arnaldo, 715 Cerqueira Cesar
01246-904 Sao Paulo SP BRAZIL
Country 4721 0
Brazil
Phone 4721 0
55 11 30617748
Fax 4721 0
Email 4721 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPaper-filtered coffee increases cholesterol and inflammation biomarkers independent of roasting degree: A clinical trial2013https://doi.org/10.1016/j.nut.2013.01.003
N.B. These documents automatically identified may not have been verified by the study sponsor.