Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000758202
Ethics application status
Approved
Date submitted
25/08/2009
Date registered
1/09/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assesment of antioxidant status in vivo and in vitro of guarana (Paullinia cupana).
Scientific title
Effects of ingestion of a beverage made with guarana powder on plasma and low density lipoprotein (LDL) susceptibility to oxidation and on antioxidant enzymes status in overweight adults
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma and LDL susceptibility to oxidation 243416 0
Antioxidant acitivity of the Enzymes Superoxide Dismutase, Catalase and Glutathione Peroxidase. 243521 0
Condition category
Condition code
Diet and Nutrition 239904 239904 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twelve (12) overweight volunteers will be instructed to gradually reduce the ingestion of coffee, tea, red wine, chocolate and other foods that contain guarana before 15 days before the visit for the blood collection and during the intervention. Consumption of juice fruits may not exceed 300ml per day and alcoholic beverage will be required to be avoided at least 2 days before each visit. Vollunteers will be asked to avoid taking any antioxidant suplement for 2 weeks beforetheir first visit and throughout the ensuing study periods. They will have their blood drawn on a twelve-hour overnight fast (T=1) and one hour after guarana consumption the second blood sample will be collected (T=2). Fifteen days after drinking the beverage made with guarana powder (3g) diluited in cold 300 ml water, two blood samples will be collected: one on a twelve-hour overnight fast (T=3) and other after the fisrt hour of drinking the beverage (T=4). Lipid profile of the volunteers will be evaluated on the begging and in the end of the intervention. Plasma and LDL at the four moments will be submitted to oxidation by copper (Cu+2) and after that the kinetics of diene conjugate generation and thiobarbituric acid reactive substance (TBARS) will be evaluated as well antioxidant activity of the enzymes gluthatione peroxidase (GPx), superoxide dismutase (SOD), and catalase (CAT) in erythrocites. Antioxidant Total Status of the plasma will be determinated. The Deoxyribonucleic acid (DNA) damage will be analyzed in blood lymphocytes using the Comet Assay. The Comet assay successfully assess interactions of
antioxidants with genotoxicants and it has also proved a valid
technique to evaluate whether antioxidant/micronutrients are
able to protect the integrity of the genetic material.
Intervention code [1] 237052 0
Other interventions
Comparator / control treatment
Subjects will be their own controls. Each one will have their parameters compared before and after the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240583 0
We will evaluated plasma total antioxidant status (TAS), the kinetics of diene conjugate generation, and thiobarbituric acid reactive substance (TBARS) contents in plasma, as well as antioxidant activity of gluthatione peroxidase (GPx), superoxide dismutase (SOD), and catalase (CAT).
Timepoint [1] 240583 0
A baseline blood sample will be collected on a twelve-hour overnight fast (T=1) and after one hour guarana consumption the second blood sample will be collected (T=2). 15 days after drinking the beverage, another blood sample will be collected one on a twelve-hour overnight fast (T=3) and other after one hour of drinking the beverage (T=4).
Secondary outcome [1] 257213 0
Commet Assay in lymphocytes.
Timepoint [1] 257213 0
A baseline blood sample will be collected on a twelve-hour overnight fast and 15 days after drinking the beverage, another blood sample will be collected one on a twelve-hour overnight fast.

Eligibility
Key inclusion criteria
Body Mass Index (BMI).: 24.90 kg/m2 < BMI> 29.90 Kg/m2 (overweight)
tryglicerides: < 400mg/dl
total cholesterol: <200 mg/dl
LDl cholesterol: from 100 to 159 mg/dL
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Vegetarian diet, pregnant , smoking, obesity, diabetes, hypertension,chronic heart disease (CHD) history, hepatic desease, regular use of supplements or drugs, sensibility to caffeine or any other chronic desease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enroled at Incor - Heart Institute (Clinical Hospital) in Sao Paulo (Brazil) by the ambulatory of chronic coronary disease.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 1928 0
Brazil
State/province [1] 1928 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 237505 0
Charities/Societies/Foundations
Name [1] 237505 0
The State of Sao Paulo Research Foundation (FAPESP)
Country [1] 237505 0
Brazil
Primary sponsor type
Individual
Name
Carolina de Aguiar Martins
Address
Av. Dr. Arnaldo, 715 - Cerq. Cesar - CEP: 01246-904 - Sao Paulo/SP - Brasil
Country
Brazil
Secondary sponsor category [1] 237017 0
Individual
Name [1] 237017 0
Elizabeth Aparecida Ferraz da Silva Torres
Address [1] 237017 0
Av. Dr. Arnaldo, 715 - Cerq. Cesar - CEP: 01246-904 - Sao Paulo/SP - Brasil
Country [1] 237017 0
Brazil
Other collaborator category [1] 820 0
Hospital
Name [1] 820 0
Heart and Coffee research group, linked to the Unit of Chronic Coronary disease of the Heart Institute-InCor, HC-FMUSP.
Address [1] 820 0
Av. Dr. Eneas de Carvalho Aguiar, 44. Cerqueira Cesar. CEP: 05403900 - Sao Paulo, SP.
Country [1] 820 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243632 0
Research Ethic Committee of The Public Health - COEP Sao Paulo University
Ethics committee address [1] 243632 0
Ethics committee country [1] 243632 0
Brazil
Date submitted for ethics approval [1] 243632 0
Approval date [1] 243632 0
05/06/2009
Ethics approval number [1] 243632 0
166/08
approval number: 1817

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

Contacts
Principal investigator
Name 29993 0
Address 29993 0
Country 29993 0
Phone 29993 0
Fax 29993 0
Email 29993 0
Contact person for public queries
Name 13240 0
Carolina de Aguiar Martins
Address 13240 0
Av. Dr. Arnaldo, 715. Cerqueira Cesar. CEP: 01246-904 - Sao Paulo.
Country 13240 0
Brazil
Phone 13240 0
55 11 30617748
Fax 13240 0
55 11 3061-7130
Email 13240 0
[email protected]
Contact person for scientific queries
Name 4168 0
Elizabeth Aparecida Ferraz da Silva Torres
Address 4168 0
Av. Dr. Arnaldo, 715. Cerqueira Cesar. CEP: 01246-904 - Sao Paulo
Country 4168 0
Brazil
Phone 4168 0
55 11 30617857
Fax 4168 0
55 11 3061-7130
Email 4168 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 AIAvaliação da atividade antioxidante in vitro e in vivo do guaraná (Paullinia cupana) em pó2010https://doi.org/10.11606/d.6.2010.tde-31012011-093906
N.B. These documents automatically identified may not have been verified by the study sponsor.