Trial Review

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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] 280454 0
Nil
Universal Trial Number (UTN)
U1111-1130-5408
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
senescence 286431 0
cardiovascular disease 286432 0
inflammation 286433 0
Condition category
Condition code
Diet and Nutrition 286686 286686 0 0
Other diet and nutrition disorders
Cardiovascular 286687 286687 0 0
Coronary heart disease
Inflammatory and Immune System 286688 286688 0 0
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] 284817 0
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] 287090 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] 287090 0
Baseline, and at 30 minute intervals for 5 hours.
Primary outcome [2] 287091 0
Chylomicron size distribution as measured by laser diffraction particle size analysis.
Timepoint [2] 287091 0
Baseline, and at 1 hour intervals for 5 hours.
Secondary outcome [1] 297347 0
Endotoxin concentration as measured by Limulus amoebocyte lysate assay.
Timepoint [1] 297347 0
Baseline, and at 1 hour intervals for 5 hours.
Secondary outcome [2] 297349 0
Peripheral Blood Mononuclear Cell (PBMC) gene expression as measured by oligonucleotide microarray.
Timepoint [2] 297349 0
Baseline, and at 30 minute intervals for 5 hours.
Secondary outcome [3] 297350 0
Plasma amino acid, glucose and fatty acid profile by gas chromatography spectrometry.
Timepoint [3] 297350 0
Baseline, and at 30 minute intervals for 5 hours.
Secondary outcome [4] 297351 0
Plasma insulin, GLP-1 and glucagon as measured by immunoassay.
Timepoint [4] 297351 0
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
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 4294 0
New Zealand
State/province [1] 4294 0
Auckland

Funding & Sponsors
Funding source category [1] 285215 0
Charities/Societies/Foundations
Name [1] 285215 0
Liggins Institute Trust
Country [1] 285215 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] 284086 0
Individual
Name [1] 284086 0
Amber Milan
Address [1] 284086 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country [1] 284086 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287218 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 287218 0
Ethics committee country [1] 287218 0
New Zealand
Date submitted for ethics approval [1] 287218 0
Approval date [1] 287218 0
03/05/2012
Ethics approval number [1] 287218 0
8026

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

Contacts
Principal investigator
Name 34149 0
Prof David Cameron-Smith
Address 34149 0
Liggins Institute University of Auckland 2-6 Park Avenue Grafton, Auckland Private Bag 92019 Auckland 1142
Country 34149 0
New Zealand
Phone 34149 0
+64 9 9231336
Fax 34149 0
Email 34149 0
[email protected]
Contact person for public queries
Name 17396 0
Amber Milan
Address 17396 0
Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142
Country 17396 0
New Zealand
Phone 17396 0
+64 9 9239975
Fax 17396 0
Email 17396 0
[email protected]
Contact person for scientific queries
Name 8324 0
David Cameron-Smith
Address 8324 0
Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142
Country 8324 0
New Zealand
Phone 8324 0
+64 9 9231336
Fax 8324 0
+64 9 373 8763
Email 8324 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
SourceTitleYear of PublicationDOI
EmbaseOlder adults have an altered chylomicron response to a high-fat meal.2016https://dx.doi.org/10.1017/S000711451500505X
EmbaseComparisons of the postprandial inflammatory and endotoxaemic responses to mixed meals in young and older individuals: A randomised trial.2017https://dx.doi.org/10.3390/nu9040354
EmbaseComparison 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.2019https://dx.doi.org/10.3390/nu11122893
N.B. These documents automatically identified may not have been verified by the study sponsor.