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Trial registered on ANZCTR


Registration number
ACTRN12612000534886
Ethics application status
Approved
Date submitted
21/05/2012
Date registered
21/05/2012
Date last updated
21/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of cooking method on the physiological responses to a red meat meal.
Scientific title
In healthy young adults aged 20-25 years, does the ingestion of charred red meat, compared with slow cooking, elicit a significantly different physiological response.
Secondary ID [1] 280509 0
Nil
Universal Trial Number (UTN)
U1111-1130-8856
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of charring of red meat on the formation of carcinogens and the effect of charred red meat ingestion on cancer risk. 286495 0
Effect of charred red meat ingestion on inflammatory and immune responses. 286496 0
Condition category
Condition code
Diet and Nutrition 286754 286754 0 0
Other diet and nutrition disorders
Cardiovascular 286755 286755 0 0
Coronary heart disease
Inflammatory and Immune System 286756 286756 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single meal of a 250g charred beef steak, 1.5 cm thick, cooked on a hot plate at 220-240oC for 4 minutes on each side, to a minimum internal temperature of 70oC and served with 20g tomato sauce on two slices of white bread. The meal consists of 3210 kJ, 37g fat, 30g carbohydrates and 77g protein. The meal is consumed for breakfast after an overnight fast (10pm to 8am). Following a two week wash-out period, participants will consume the un-charred beef meal as a control.
Intervention code [1] 284882 0
Lifestyle
Comparator / control treatment
A single meal of a 250g un-charred beef steak, 1.5 cm thick, cooked under sous-vide conditions (vacuum sealed) in a water bath at 80oC for 3 hours, to a minimum internal temperature of 70oC and served with 20g tomato sauce on two slices of white bread. The meal consists of 3210 kJ, 37g fat, 30g carbohydrates and 77g protein. The meal is consumed for breakfast after an overnight fast (10pm to 8am) and followed by a two week wash-out period between study meals.
Control group
Active

Outcomes
Primary outcome [1] 287144 0
Inflammatory cytokine profile of IL-6, IL-1, TNF-a, MCP-1 and CRP as measured by immunolite fluorescent analysis in plasma samples.
Timepoint [1] 287144 0
Baseline immediately prior to meal commencement, and at 60 minute intervals thereafter for 4 hours.
Primary outcome [2] 287145 0
Oxidative stress markers, including total antioxidant status (TAS), antioxidant enzymes (superoxidise dismutase (SOD) and catalase (CAT)) and oxidative stress marker (malondialdehyde (MDA)) via calorimetric and fluorescent assay analysis.
Timepoint [2] 287145 0
Baseline immediately prior to meal commencement, and at 60 minute intervals thereafter for 4 hours.
Secondary outcome [1] 297483 0
Plasma amino acid, glucose and fatty acid profile by gas chromatography spectrometry.
Timepoint [1] 297483 0
Baseline immediately prior to meal commencement, and at 60 minute intervals thereafter for 4 hours.
Secondary outcome [2] 297484 0
Plasma insulin, GLP-1 and glucagon as measured by immunoassay.
Timepoint [2] 297484 0
Baseline immediately prior to meal commencement, and at 60 minute intervals thereafter for 4 hours.

Eligibility
Key inclusion criteria
Aged 20-25 years old
Non-vegetarian
No known allergy to gluten
Minimum age
20 Years
Maximum age
25 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Vegetarian
Food allergy to gluten
Family history of diabetes
Family history of heart disease
Anti-inflammatory pharmaceutical use
BMI >30

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)
Participants will be recruited by public notices and advertisements placed in community newspapers. Telephone screening will firstly identify participants within the required age range and exclude those likely to be experiencing exclusion factors (family history of diabetes and heart disease, anti-inflammatory pharmaceutical use and BMI >30). Participants meeting this screening will be forwarded the Participant Information Sheet and Consent form. The participants will be invited to a face to face meeting with the researchers to ensure the Participant Information Sheet has been read and understood. If written consent is provided, a written general health questionnaire and baseline blood sample will be drawn to verify inclusion criteria by excluding diabetes and risk of heart disease. Participants meeting the inclusion requirement will be invited to undertake the study and a date provided for the first breakfast meal. Allocation will be concealed by use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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 outside Australia
Country [1] 4322 0
New Zealand
State/province [1] 4322 0
Auckland

Funding & Sponsors
Funding source category [1] 285269 0
University
Name [1] 285269 0
Start-up Research Grant from the University of Auckland
Address [1] 285269 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country [1] 285269 0
New Zealand
Primary sponsor type
Individual
Name
David Cameron-Smith
Address
The University of Auckland, Private Bag 92019, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284133 0
Individual
Name [1] 284133 0
Amber Milan
Address [1] 284133 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country [1] 284133 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287285 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 287285 0
UAHPEC Secretary
Research Integrity Unit
Level 10, Building 620
49 Symonds Street
Auckland 1010
Ethics committee country [1] 287285 0
New Zealand
Date submitted for ethics approval [1] 287285 0
Approval date [1] 287285 0
14/03/2012
Ethics approval number [1] 287285 0
7947

Summary
Brief summary
Red meat is a major component of the typical western diet. Despite providing between 30-50% of the daily intake of protein and an equivalent proportion of daily iron/zinc intake, red meat intake also positively correlates to colorectal cancer risk. The cancer risks from red meat depend in part on the cooking methods. Burnt, barbequed or red meat cooked at high temperatures have higher concentrations of a diverse array of pro-inflammatory, pro-oxidative and carcinogenic compounds including; heterocyclic amines (HCAs), polycyclic aromatic hydrocarbons ( PAHs) and N-nitroso compounds (NOCs). These potentially carcinogenic compounds are likely to initiate an oxidative stress response in the body. However, there is very limited data on what impact the methods of cooking red meat have on the digestion of the meat protein, and also responses elicited by hormonal and acute inflammatory pathways.
Trial website
Trial related presentations / publications
Nuora, A. Chiang, VS; Milan, AM; Tarvaninen, M; Pundir, S; Quek, SY; Smith, GC; Markworth, JF; Ahotupa, M; Cameron-Smith, D; Linderborg, KM. The impact of beef steak thermal processing on lipid oxidation and postprandial inflammation related responses. Food Chemistry; 184:57-64 (2015).
Chiang, VSC; Pundir, S; Milan, A; Smith, G; Markworth, JF; Cameron-Smith, D. Comprehensive profiling of the metabolomics and hormonal responses to a red meat meal. Food Structures, Digestion and Health, 2nd International Conference, Melbourne, Australia, October 21-24 (2013).
Public notes

Contacts
Principal investigator
Name 34192 0
Prof David Cameron-Smith
Address 34192 0
Liggins Institute University of Auckland 2-6 Park Avenue Grafton, Auckland Private Bag 92019 Auckland 1142
Country 34192 0
New Zealand
Phone 34192 0
+64 9 9239975
Fax 34192 0
Email 34192 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 17439 0
Miss Amber Milan
Address 17439 0
Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142
Country 17439 0
New Zealand
Phone 17439 0
+64 9 9239975
Fax 17439 0
Email 17439 0
a.milan@auckland.ac.nz
Contact person for scientific queries
Name 8367 0
Prof David Cameron-Smith
Address 8367 0
Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142
Country 8367 0
New Zealand
Phone 8367 0
+64 9 9231336
Fax 8367 0
Email 8367 0
d.cameron-smith@auckland.ac.nz

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