Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000147583
Ethics application status
Approved
Date submitted
2/02/2015
Date registered
17/02/2015
Date last updated
12/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The acute effects of triacylglycerol structure of palmitic acid rich fats on chylomicron composition in lean subjects and those with the Metabolic Syndrome.
Scientific title
In middle aged men with the Metabolic Syndrome, does the ingestion of palmitic acid rich fats, compared with palmitic acid poor fats, acutely affect postprandial chylomicron composition.
Secondary ID [1] 286071 0
Nil
Universal Trial Number (UTN)
U1111-1166-6382
Trial acronym
PALMS: Postprandial effects of Acute Lipid ingestion in the Metabolic Syndrome
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 294065 0
Condition category
Condition code
Metabolic and Endocrine 294365 294365 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Iso-energetic meals, consisting of a muffin and a milkshake, to provide ~ 3.54MJ (846 kcal), 14g protein, 85g carbohydrate and 50g of test fat will be fed on four different occasions separated by at least one week. Intervention test fats:
1. Palm olein (PO)
2. Chemically interesterified palm olein (IPO)
3. Lard (L)
Intervention code [1] 291059 0
Lifestyle
Intervention code [2] 291146 0
Treatment: Other
Comparator / control treatment
Iso-energetic meals, consisting of a muffin and a milkshake, to provide ~ 3.54MJ (846 kcal), 14g protein, 85g carbohydrate and 50g of test fat will be fed on four different occasions separated by at least one week. Control test fats: High oleic sunflower oil (SO): Control
Control group
Active

Outcomes
Primary outcome [1] 294187 0
Difference in chylomicron TAG concentration measured by enzymatic immunoassay after test fat ingestion relative to control fat
Timepoint [1] 294187 0
Baseline and hourly for 5 hours post-meal at each visit
Primary outcome [2] 294188 0
Differences in chylomicron TAG composition and regio-isomerisation measured by lipidomic analysis after test fat ingestion relative to control fat
Timepoint [2] 294188 0
Baseline and hourly for 5 hours post-meal at each visit
Primary outcome [3] 294189 0
Differences in chylomicron particle size measured by dynamic light scattering after test fat ingestion relative to control subjects
Timepoint [3] 294189 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [1] 312723 0
Differences in immune cell activation by peripheral blood mononuclear cell gene expression of inflammatory cytokines measured by quantitative polymerase chain reaction after test fat ingestion relative to control subjects
Timepoint [1] 312723 0
Baseline, 2 hours and 4 hours post-meal at each visit
Secondary outcome [2] 312725 0
Differences in plasma metabolites (including acyl-carnitines to quantify lipid peroxidation) measured by GC-MS after test fat ingestion relative to control fat
Timepoint [2] 312725 0
Baseline and hourly for 5 hours post-meal at each visit

Eligibility
Key inclusion criteria
Group 1:
45-60 years old
BMI of 18-25 kg/m2
Healthy (no current or past history of the Metabolic Syndrome as defined by the International Diabetes Federation)

Group 2:
45-60 years old
BMI greater than 25 kg/m2
Metabolic Syndrome as defined by the International Diabetes Federation: central obesity (waist circumference greater than/equal to 94cm PLUS any two of:
* raised TG concentrations (greater than/equal to 1.7 mmol/L or undergoing treatment)
* reduced HDL-C (<1.03 mmol/L or undergoing treatment)
* raised blood pressure (greater than/equal to 130/85 mmHg or undergoing treatment)
* raised fasting plasma glucose (greater than/equal to 5.6 mmol/L or previously diagnoses T2DM)
Minimum age
45 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
History of CVD disease/complications (myocardial infarction, angina, stroke)
History of cancer
Pre-existing diabetes
Self reported alcohol intake exceeding a moderate intake (>28 units/week)
Abnormal liver function or haematology

Study design
Purpose of the study
Treatment
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). 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
23/02/2015
Actual
23/02/2015
Date of last participant enrolment
Anticipated
Actual
1/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 6623 0
New Zealand
State/province [1] 6623 0

Funding & Sponsors
Funding source category [1] 290670 0
Commercial sector/Industry
Name [1] 290670 0
Malaysian Palm Oil Board
Country [1] 290670 0
Malaysia
Primary sponsor type
Commercial sector/Industry
Name
Auckland UniServices
Address
Auckland UniServices Ltd
70 Symonds Street
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 289363 0
Commercial sector/Industry
Name [1] 289363 0
Malaysian Palm Oil Board
Address [1] 289363 0
Malaysian Palm Oil Board
No. 6, Persiaran Institusi
Bandar Baru Bangi
43000 Kajang, Selangor
Country [1] 289363 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292300 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 292300 0
Ethics committee country [1] 292300 0
New Zealand
Date submitted for ethics approval [1] 292300 0
Approval date [1] 292300 0
21/01/2015
Ethics approval number [1] 292300 0
14/STH/184

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

Contacts
Principal investigator
Name 54482 0
Prof David Cameron-Smith
Address 54482 0
Liggins Institute University of Auckland 2-6 Park Avenue Grafton, Auckland Private Bag 92019 Auckland 1142
Country 54482 0
New Zealand
Phone 54482 0
+64 9 923 1336
Fax 54482 0
Email 54482 0
[email protected]
Contact person for public queries
Name 54483 0
Amber Milan
Address 54483 0
Liggins Institute University of Auckland 2-6 Park Avenue Grafton, Auckland Private Bag 92019 Auckland 1142
Country 54483 0
New Zealand
Phone 54483 0
+64 9 923 1336
Fax 54483 0
Email 54483 0
[email protected]
Contact person for scientific queries
Name 54484 0
David Cameron-Smith
Address 54484 0
Liggins Institute University of Auckland 2-6 Park Avenue Grafton, Auckland Private Bag 92019 Auckland 1142
Country 54484 0
New Zealand
Phone 54484 0
+64 9 923 1336
Fax 54484 0
Email 54484 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
No additional documents have been identified.