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Trial registered on ANZCTR

Registration number

ACTRN12612000515897

Ethics application status

Approved

Date submitted

11/05/2012

Date registered

15/05/2012

Date last updated

1/11/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Do older people experience a greater post-meal inflammatory response to a fast food breakfast?

Scientific title

In older adults aged 70-75 years versus younger adults aged 20-25 years, does the ingestion of a high fat fast food breakfast, compared with a lower fat 'healthy' breakfast, elicit a greater post-meal inflammatory response.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1130-5408

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

senescence

cardiovascular disease

inflammation

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 fast food breakfast of two sausage and egg breakfast sandwiches, and a hash brown, consisting of 4395 kJ, 63g fat, 75g carbohydrate and 43g protein. The meal is consumed for breakfast after an overnight fast (7pm to 7am) and followed by a two week wash-out period between study meals.

Intervention code [1]

Lifestyle

Comparator / control treatment

A single meal of a 'healthy' breakfast of rolled oats prepared in skim milk, low fat cottage cheese with two fresh apricots, one slice whole wheat toast with reduced fat peanut butter, consisting of 2616 kJ, 17.4g fat, 75g carbohydrate and 43g protein. The meal is consumed for breakfast after an overnight fast (7pm to 7am) 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, and at 30 minute intervals for 5 hours.

Primary outcome [2]

Chylomicron size distribution as measured by laser diffraction particle size analysis.

Timepoint [2]

Baseline, and at 1 hour intervals for 5 hours.

Secondary outcome [1]

Endotoxin concentration as measured by Limulus amoebocyte lysate assay.

Timepoint [1]

Baseline, and at 1 hour intervals for 5 hours.

Secondary outcome [2]

Peripheral Blood Mononuclear Cell (PBMC) gene expression as measured by oligonucleotide microarray.

Timepoint [2]

Baseline, and at 30 minute intervals for 5 hours.

Secondary outcome [3]

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

Timepoint [3]

Baseline, and at 30 minute intervals for 5 hours.

Secondary outcome [4]

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

Timepoint [4]

Baseline, and at 30 minute intervals for 5 hours.

Eligibility

Key inclusion criteria

Aged 20-25 or 70-75 years old
Non-vegetarian
No allergies to peanuts, dairy, gluten

Minimum age

20 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Vegetarian
Food allergies to peanuts, dairy, 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 ranges 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

1/07/2012

Actual

19/10/2012

Date of last participant enrolment

Anticipated

Actual

9/07/2013

Date of last data collection

Anticipated

Actual

30/07/2013

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Liggins Institute Trust

Address [1]

The Liggins Institute Trust
PO Box 110085, Auckland 1148

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]

03/05/2012

Ethics approval number [1]

8026

Summary

Brief summary

Meals high in fat cause a marked postprandial increase in low-grade inflammation. Although short-term, the resulting inflammatory response may have implications in long-term risk for chronic illness such as cardiovascular disease (CVD). It is unknown whether the postprandial inflammatory response to high-fat meals differs in older adults, and is still not clear how digestion and metabolism of fats is affected by age.

This study aims to analyse the digestive, physiological, inflammatory and immune responses to a single meal in young adults compared with older adults, of either a ‘fast-food’ breakfast (high in saturated fat and calories), or a ‘healthy’ breakfast (low in saturated fat, following dietary guidelines set out by The Australian Guide to Healthy Eating).

Trial website

Trial related presentations / publications

Milan AM, D’Souza RF, Pundir S, Pileggi CA, Thorstensen EB, Barnett MP, Markworth JF, Cameron-Smith D, Mitchell C. Older adults have delayed amino acid absorption after a high protein mixed breakfast meal. The journal of nutrition, health & aging. 2015 Oct 1;19(8):839-45.
Milan AM, Nuora A, Pundir S, Pileggi CA, Markworth JF, Linderborg KM, Cameron-Smith D. Older adults have an altered chylomicron response to a high-fat meal. British Journal of Nutrition. 2016 Mar 14;115(05):791-9
Milan, A. M., Pundir, S., Pileggi, C. A., Markworth, J. F., Lewandowski, P. A., & Cameron-Smith, D. (2017). Comparisons of the Postprandial Inflammatory and Endotoxaemic Responses to Mixed Meals in Young and Older Individuals: A Randomised Trial. Nutrients, 9(4), 354.
Milan, A; Pundir, S; Pileggi, CA; Markworth, JF; Roy, NC; Cameron-Smith, D. (2015). The impact of age on the inflammatory, endotoxaemic, and oxidative stress responses to a high fat meal. Joint Annual Scientific Meeting of the Nutrition Society of New Zealand and the Nutrition Society of Australia, Wellington, New Zealand, December 1-4 [Presentation].
Milan, A; Nuora, A; Pundir, S; Pileggi, C; Markworth JF; Linderborg, K; Cameron-Smith, D. Postprandial fatty acid appearance is altered in older adults after high or low fat mixed meals. Food Structures, Digestion and Health, 3rd International Conference, Wellington, New Zealand, October 28-30 (2015) [Poster].
Milan, A; Nuora, A; Villa, K; Linderborg, K; Cameron-Smith, D. Acute dynamic and compositional changes in chylomicrons after a high-fat breakfast meal: Impact of age. Nutrition Society of New Zealand Conference: Queenstown Research Week, August 28-29 (2014) [Presentation]..
Milan, A; Pundir, S; Pileggi, C; Chiang, V; Lee, W; Markworth JF; Cameron-Smith, D. Acute chylomicronaemic and endotoxaemic responses to a high fat breakfast meal: Impact of age. Food Structures, Digestion and Health, 2nd International Conference, Melbourne, Australia, October 21-24 (2013) [Poster].

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 9231336

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

+64 9 373 8763

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	Older adults have an altered chylomicron response to a high-fat meal.	2016	https://dx.doi.org/10.1017/S000711451500505X
Embase	Comparisons of the postprandial inflammatory and endotoxaemic responses to mixed meals in young and older individuals: A randomised trial.	2017	https://dx.doi.org/10.3390/nu9040354
Embase	Comparison of the acute postprandial circulating B-vitamin and vitamer responses to single breakfast meals in young and older individuals: Preliminary secondary outcomes of a randomized controlled trial.	2019	https://dx.doi.org/10.3390/nu11122893

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

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