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Trial registered on ANZCTR


Registration number
ACTRN12609000824268
Ethics application status
Approved
Date submitted
15/09/2009
Date registered
22/09/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Beverage prepared with grape by-product: effect on oxidative stress and coronary artery disease markers in human beings
Scientific title
Effects of ingestion of a beverage prepared with grape by-product on plasma and low density lipoprotein (LDL) to oxidation and on antioxidant status in healthy individuals: a randomized, controlled, crossover clinical trial
Universal Trial Number (UTN)
U1111-1111-8188
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma and LDL susceptibility to oxidation 243838 0
Antioxidant activity of the enzymes Superoxide Dismutase, Catalase and Glutathione Peroxidase 243839 0
Condition category
Condition code
Diet and Nutrition 240012 240012 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixteen healthy individuals will be enrolled in a randomized, controlled, crossover clinical trial either to drink 300 mL of the beverage made with 4,8 % of the grape pomace flour (GPF) from the grape juice or commercial grape juice contents 1 % of grape pulp once daily for two weeks. After fourteen days of washout, the same individuals will drink the other beverage, commercial juice or from grape pomace, for more fourteen days. Blood samples of the individuals will be collected at baseline, after two weeks of intervention and the same protocol will be performed after fourteen days of washout.
Intervention code [1] 241276 0
Prevention
Comparator / control treatment
Subjects will be their own controls. They will be enrolled in a randomized, controlled, crossover clinical trial in two different time.
Control group
Placebo

Outcomes
Primary outcome [1] 240912 0
We will evaluated plasma total antioxidant status (TAS), the kinetics of diene conjugate generation and thiobarbituric acid reactive substance (TBARS) contents in LDL , as well as antioxidant activity of gluthatione peroxidase (GPx), superoxide dismutase (SOD), and catalase (CAT).
Timepoint [1] 240912 0
Blood samples of the individuals will be collected at baseline, after two weeks of intervention and the same protocol will be performed after fourteen days of washout
Primary outcome [2] 252956 0
Triacylglycerols, total cholesterol and its fractions, C-reactive protein, Interleukin-6 and tumor necrosis factor alpha (TNF-alpha) will be evaluated at the beginning and end of the experiment.
Timepoint [2] 252956 0
Blood samples of the individuals will be collected at baseline, after two weeks of intervention and the same protocol will be performed after fourteen days of washout
Secondary outcome [1] 257621 0
Deoxyribonucleic acid (DNA) damage will be analyzed in blood lymphocytes using the Comet Assay.
Timepoint [1] 257621 0
Blood samples of the individuals will be collected at baseline, after two weeks of intervention and the same protocol will be performed after fourteen days of washout

Eligibility
Key inclusion criteria
Body Mass Index (BMI): great than 19 kg/m2 and less than30 kg/m2,
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant, vegetarian diet, smoking, obesity, hypertension, use of supplements or drugs

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)
Subjects will be enroled at Public Healthy Scholl in São Paulo city, Brazil. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by random drawing
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2140 0
Brazil
State/province [1] 2140 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 243738 0
University
Name [1] 243738 0
University of Sao Paulo
Address [1] 243738 0
Av. Dr. Arnaldo, 715 - Cerqueira Cesar
Sao Paulo/SP, Brazil
CEP 05468-901
Country [1] 243738 0
Brazil
Primary sponsor type
Individual
Name
Marcela Piedade Monteiro
Address
Av. Dr. Arnaldo, 715 - Cerqueira Cesar
Sao Paulo/SP, Brazil
CEP 05468-901
Country
Brazil
Secondary sponsor category [1] 237099 0
Individual
Name [1] 237099 0
Elizabeth Aparecida Ferraz da Silva Torres
Address [1] 237099 0
Av. Dr. Arnaldo, 715 - Cerqueira Cesar
Sao Paulo/SP, Brazil
CEP 05468-901
Country [1] 237099 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243860 0
Research Ethic Committee of the Public Health - Sao Paulo University
Ethics committee address [1] 243860 0
Av. Dr. Arnaldo, 715 - Cerqueira Cesar
Sao Paulo/SP, Brazil
CEP 05468-901
Ethics committee country [1] 243860 0
Brazil
Date submitted for ethics approval [1] 243860 0
Approval date [1] 243860 0
18/03/2009
Ethics approval number [1] 243860 0
074/09 approval number 1853

Summary
Brief summary
The aim of this study i to evaluate the effect of a beverage with the grape pomace flour from the grape juice and to evaluate its effect on oxidative stress and coronary artery disease marker in human beings. Sixteen healthy individuals will be enrolled in a randomized, controlled, crossover clinical trial to take the beverage made of the grape pomace flour (GPF) from the grape juice or commercial grape juice for two weeks. Blood samples of the individuals will be collected at baseline, after two weeks of intervention and the same protocol will be performed after fourteen days of washout. Triacylglycerols, total cholesterol and its fractions, C-reactive protein, IL-6 and TNF-a will be evaluated at the beginning and end of the experiment. Plasma and LDL will be submitted to the oxidation by Copper (Cu+2) at the four moments, followed by the measurement of the formed products of lipid peroxidation: the concentration of TBARs (Thiobarbituric acid-reactive substances) and the formation of conjugated dienes using spectrophotometric methods. The total antioxidant status of the plasma (TAS) and Oxygen Radical Absorbing Capacity will be likewise analyzed. Superoxide dismutase, catalase and glutathione peroxidase activities will be determined in erytrocitys. And analyzed DNA damage by comet Assay.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30285 0
Address 30285 0
Country 30285 0
Phone 30285 0
Fax 30285 0
Email 30285 0
Contact person for public queries
Name 13532 0
Marcela Piedade Monteiro
Address 13532 0
Av. Dr. Arnaldo, 715 Cerqueira Cesar
Sao Paulo/SP Brazil
CEP 01246-904
Country 13532 0
Brazil
Phone 13532 0
55 11 3061-7748
Fax 13532 0
55 11 3061-7130
Email 13532 0
mamonte@usp.br
Contact person for scientific queries
Name 4460 0
Elizabeth Aparecida Ferraz da Silva Torres
Address 4460 0
Av. Dr. Arnaldo, 715 Cerqueira Cesar
Sao Paulo/SP Brazil
CEP 01246-904
Country 4460 0
Brazil
Phone 4460 0
55 11 3061-7857
Fax 4460 0
55 11 3061-7130
Email 4460 0
eatorres@usp.br

No information has been provided regarding IPD availability
Summary results
No Results