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Trial registered on ANZCTR


Registration number
ACTRN12612000058875
Ethics application status
Approved
Date submitted
10/01/2012
Date registered
11/01/2012
Date last updated
11/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effects of consuming a single high fat meal alone, cocoa alone, or consuming both a high fat meal with a cocoa drink on antioxidants, oxidative stress and inflammatory cytokines in healthy human volunteers
Scientific title
In healthy humans, does simultaneous consumption of a cocoa drink modulate acute phase postprandial effects, compared to the effects of consuming a high fat meal alone, on antioxidant status, oxidative stress markers and inflammatory cytokine levels?
Secondary ID [1] 279698 0
Nil
Universal Trial Number (UTN)
U1111-1126-9895
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Changes to antioxidant status, oxidative stress markers and inflammatory cytokine levels (all in circulation) in response to an unhealthy (high fat) meal 285527 0
Condition category
Condition code
Diet and Nutrition 285721 285721 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 285736 285736 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single Cocoa drink (12g cocoa powder + 16g sugar + 400mL hot water) alone, or on a separate occasion in combination with a high fat meal (50g dehydrated potato + 250mL hot water + 100g butter). Each intervention and control meal (all four - 1=cocoa alone, 2=fatty meal alone, 3=water alone, 4= cocoa drink + fatty meal) was consumed once by each participant (within 15min of baseline blood collection), in a random order, with a minimum of a week washout between meals. This meant each participant was their own control.
Intervention code [1] 283989 0
Prevention
Comparator / control treatment
High fat meal (50g dehydrated potato + 250mL hot water + 100g butter) alone, or water alone (400ml cold water)
Control group
Active

Outcomes
Primary outcome [1] 286241 0
Antioxidant measures (all as plasma assays using 96-well plate format): Total antioxidant status (TEAC method, modified from Miller, et al. 1994), Superoxide dismutase (SOD) levels (Cayman chemicals kit), Catalase (CAT) activity (cayman chemicals kit)
Timepoint [1] 286241 0
baseline (0h), 1h, 2h and 3h
Primary outcome [2] 286242 0
Oxidative stress: plasma Malondialdehyde (MDA) (Northwest life sciences kit), White blood cell DNA 8-hydroxy-2-deoxy-guanosine (8-OH-2-dG) levels (DNA isolated using tri-reagent, then digested with nuclease P1 and shrimp alkaline phasphatase from Sigma-aldrich, then run as a EIA kit from StressMarq Biosciences).
Timepoint [2] 286242 0
baseline (0h), 1h, 2h and 3h
Primary outcome [3] 286245 0
Inflammatory cytokines (plasma): IL-1beta, IL-6, IL-8, TNF-alpha, GM-CSF. These were assayed on a BioRad Bioplex using 5-plex inflammatory cytokine assay kits from Invitrogen.
Timepoint [3] 286245 0
baseline (0h), 1h, 2h and 3h
Secondary outcome [1] 295446 0
Blood biochemistry: Total cholesterol, HDL, LDL, Triglycerides, blood glucose, and insulin.
Timepoint [1] 295446 0
baseline (0h), 1h, 2h and 3h

Eligibility
Key inclusion criteria
young age (18y-35y), good health (no known illnesses that will affect study, healthy BMI, healthy blood pressure, healthy glucose range, healthy for blood biochemistry markers), not taking supplements / antioxidants / drugs that would interfere with study measures, willing to volunteer, willing to undergo blood tests, lack of allergies to test foods, non-elite athlete / not undertaking large amounts of exercise, not pregnant, does not have blood disorders, and has not been diagnosed with any condition that may affect results.
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Outside of the target age, poor health parameters (illnesses known to affect the primary measures of the study, BMI outside of the healthy range, high or low blood pressure, blood glucose outside of the healthy range, abnormalities in blood lipid levels), taking supplements / antioxidants (large amounts) / drugs / medications known to alter study measures, allergies to foods in test meals, not willing to undergo blood sampling, elite athlete / undertaking heavy exercise, pregnancy / attempting to become pregnant, have a blood clotting or other blood disorder, or have been diagnosed with a condition known to affect study measurements.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284482 0
University
Name [1] 284482 0
Deakin University
Address [1] 284482 0
Pigdons Road, Waurn Ponds, Geelong, Victoria 3216
Country [1] 284482 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Pigdons Road, Waurn Ponds, Geelong, Victoria 3216
Country
Australia
Secondary sponsor category [1] 283406 0
None
Name [1] 283406 0
Address [1] 283406 0
Country [1] 283406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286461 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 286461 0
Pigdons Road, Waurn Ponds, Geelong, Victoria 3216
Ethics committee country [1] 286461 0
Australia
Date submitted for ethics approval [1] 286461 0
Approval date [1] 286461 0
21/08/2008
Ethics approval number [1] 286461 0
EC 100-2008

Summary
Brief summary
Fatty meals can cause damage to the body, known as oxidative damage. They do this by decreasing protective antioxidant levels/activity, through using them up. When this oxidative damage occurs, an inflammatory response can occur, with the release of inflammatory signalling molecules (cytokines). Over time oxidative damage and inflammation can lead to detrimental health effects such as cardiovascular disease, diabetes and cancer. This current study aims to determine if consumption of an antioxidant containing cocoa drink at the same time as a high fat meal can improve the body's own antioxidant defenses, as well as reduce oxidative damage markers and inflammatory cytokine levels. We anticipated that cocoa consumed at the same time should help to stop the unhealthy effects (eg. lower antioxidants, increased oxidative stress, and higher inflammatory response) caused by a high fat meal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33609 0
Address 33609 0
Country 33609 0
Phone 33609 0
Fax 33609 0
Email 33609 0
Contact person for public queries
Name 16856 0
Dr Paul Lewandowski
Address 16856 0
School of Medicine, Deakin University, Locked bag 2000, Geelong, VIC 3216.
Country 16856 0
Australia
Phone 16856 0
+61352271111
Fax 16856 0
Email 16856 0
paul.lewandowski@deakin.edu.au
Contact person for scientific queries
Name 7784 0
Dr Paul Lewandowski
Address 7784 0
School of Medicine, Deakin University, Locked bag 2000, Geelong, VIC 3216.
Country 7784 0
Australia
Phone 7784 0
+61352271111
Fax 7784 0
Email 7784 0
paul.lewandowski@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary