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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]

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.

Effect of charred red meat ingestion on inflammatory and immune responses.

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Cardiovascular

Coronary heart disease

Inflammatory and Immune System

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]

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]

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]

Baseline immediately prior to meal commencement, and at 60 minute intervals thereafter for 4 hours.

Primary outcome [2]

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]

Baseline immediately prior to meal commencement, and at 60 minute intervals thereafter for 4 hours.

Secondary outcome [1]

Plasma amino acid, glucose and fatty acid profile by gas chromatography spectrometry.

Timepoint [1]

Baseline immediately prior to meal commencement, and at 60 minute intervals thereafter for 4 hours.

Secondary outcome [2]

Plasma insulin, GLP-1 and glucagon as measured by immunoassay.

Timepoint [2]

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

Sex

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

1/06/2012

Actual

25/06/2012

Date of last participant enrolment

Anticipated

Actual

19/07/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Start-up Research Grant from the University of Auckland

Address [1]

The University of Auckland, Private Bag 92019, Auckland 1142

Country [1]

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]

Individual

Name [1]

Amber Milan

Address [1]

The University of Auckland, Private Bag 92019, Auckland 1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Auckland Human Participants Ethics Committee

Ethics committee address [1]

UAHPEC Secretary
Research Integrity Unit
Level 10, Building 620
49 Symonds Street
Auckland 1010

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

14/03/2012

Ethics approval number [1]

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

Prof David Cameron-Smith

Address

Liggins Institute University of Auckland 2-6 Park Avenue Grafton, Auckland Private Bag 92019 Auckland 1142

Country

New Zealand

Phone

+64 9 9239975

Fax

d.cameron-smith@auckland.ac.nz

Contact person for public queries

Name

Amber Milan

Address

Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 9239975

Fax

a.milan@auckland.ac.nz

Contact person for scientific queries

Name

David Cameron-Smith

Address

Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 9231336

Fax

d.cameron-smith@auckland.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	Plasma elemental responses to red meat ingestion in healthy young males and the effect of cooking method.	2019	https://dx.doi.org/10.1007/s00394-018-1620-6
Embase	Comparable postprandial amino acid and gastrointestinal hormone responses to beef steak cooked using different methods: A randomised crossover trial.	2020	https://dx.doi.org/10.3390/nu12020380

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically