Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001246279
Ethics application status
Approved
Date submitted
18/07/2018
Date registered
24/07/2018
Date last updated
24/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Classic Coca cola enriched with and without vitamin C on metabolic status and oxidative stress in young men.
Scientific title
Effects of Classic Coca cola enriched with and without vitamin C on metabolic status and oxidative stress in young men.
Secondary ID [1] 295589 0
None
Universal Trial Number (UTN)
U1111-1217-5932
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress
 308892 0
Condition category
Condition code
Metabolic and Endocrine 307800 307800 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aimed to determine the metabolic effects and induction of oxidative stress related to consuming Coca cola in young men and to find out if adding vitamin C (ascorbate) can mitigate these effects.
Methods: Oxidative stress markers (levels of total antioxidant status (TAS), total oxidant status (TOS), oxidative stress index (OSI)), as well as metabolic parameters (IGF1 and IGFBP-3, fasting serum insulin and fasting serum glucose) in serum of healthy subjects will be determined. These results will be compared with the 15-day after the intervention. Subjects will be randomly assigned to two groups: 1: Classic Coca cola without vitamin C and 2: Classic Coca cola with 2 g vitamin C per liter (mixed in the beverage). The dose administered will be 2 liters daily in each group during 15 days. Patients will receive a two-liter container of the drink daily according to the group to which they belong. They will be informed that they can not take another different drink and the next day they will be given a new container replacing the empty container.
Intervention code [1] 301889 0
Prevention
Comparator / control treatment
Control group include subjetcs randomly assigned for consuming Classic Coca cola without vitamin C
Control group
Active

Outcomes
Primary outcome [1] 306790 0
Serology: Oxidative stress markers (total antioxidant status, total oxidant status, lipid hydroperoxide) meassured by Spectrophotometry as a composite primary outcome.
Timepoint [1] 306790 0
4 weeks.
Primary outcome [2] 306812 0
Metabolic parameters like Insulin-like Grow Factor-1 and binding protein 3, fasting serum insulin and fasting serum glucose meassured in serum by immunoradiometry as a composite primary outcome.
Timepoint [2] 306812 0
4 weeks
Secondary outcome [1] 349656 0
Adverse events reported (nausea, vomiting, esophageal reflux, gastritis), these will be evaluated clinically.
Timepoint [1] 349656 0
1 month post-intervention.

Eligibility
Key inclusion criteria
Healthy subjects.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with chronic systemic diseases (cardiovascular, pulmonary, liver, renal, or hematologic diseases), malignancies, or who chronically used medication will be excluded from the study

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All of the statistical analyses will be performed using SPSS for Windows version 22.0 (SPSS, Chicago, IL, USA). Baseline and after 15-days differences of TAS and TOS levels will be calculated; Kolmogorov-Smirnov tests will be used to test the normality of data distribution. The data will be expressed as arithmetic means and standard deviations. Independent sample t-test and Mann-Whitney U-test will be used in normally and non-normally distributed continuous variables between groups, respectively. Paired t-tests and Wilcoxon rank tests will be used to compare the changes within each group. Pearson’s correlation analysis will be used to examine the association of oxidative stress parameters and metabolic activities in all groups. A two-sided P value <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/07/2018
Date of last participant enrolment
Anticipated
13/08/2018
Actual
Date of last data collection
Anticipated
17/09/2018
Actual
Sample size
Target
20
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 10667 0
Mexico
State/province [1] 10667 0
Mexico

Funding & Sponsors
Funding source category [1] 300169 0
Self funded/Unfunded
Name [1] 300169 0
Andres Tirado Sanchez
Country [1] 300169 0
Mexico
Primary sponsor type
Individual
Name
Andres Tirado Sanchez
Address
Hospital General de Zona No. 29, Instituto Mexicano del Seguro Social. Av. 510 No. 100 Esq. Zapata, Col. Unidad San Juan de Aragón, Distrito Federal. C.P. 07920, México.
Country
Mexico
Secondary sponsor category [1] 299577 0
None
Name [1] 299577 0
NONE
Address [1] 299577 0
NONE
Country [1] 299577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301000 0
Comité Local de Investigación en Salud 3003, Instituto Mexicano del Seguro Social
Ethics committee address [1] 301000 0
Ethics committee country [1] 301000 0
Mexico
Date submitted for ethics approval [1] 301000 0
04/06/2018
Approval date [1] 301000 0
18/06/2018
Ethics approval number [1] 301000 0
IMSS121-4-2018

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

Contacts
Principal investigator
Name 85554 0
Dr Andres Tirado Sanchez
Address 85554 0
Hospital General de Zona No. 29, Av. 510 No. 100 Esq Zapata, Col. Unidad San Juan de Aaragón, C.P. 07920, D.F. Mexico.
Country 85554 0
Mexico
Phone 85554 0
+52 55 27442811
Fax 85554 0
Email 85554 0
[email protected]
Contact person for public queries
Name 85555 0
Andres Tirado Sanchez
Address 85555 0
Hospital General de Zona No. 29, Av. 510 No. 100 Esq Zapata, Col. Unidad San Juan de Aaragón, C.P. 07920, D.F. Mexico.
Country 85555 0
Mexico
Phone 85555 0
+52 55 27442811
Fax 85555 0
Email 85555 0
[email protected]
Contact person for scientific queries
Name 85556 0
Andres Tirado Sanchez
Address 85556 0
Hospital General de Zona No. 29, Av. 510 No. 100 Esq Zapata, Col. Unidad San Juan de Aaragón, C.P. 07920, D.F. Mexico.
Country 85556 0
Mexico
Phone 85556 0
+52 55 27442811
Fax 85556 0
Email 85556 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
No additional documents have been identified.