Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000117011
Ethics application status
Approved
Date submitted
1/02/2010
Date registered
3/02/2010
Date last updated
3/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The TOP study: The effect of Thermally Oxidised Polyunsaturated (TOP) fat on post-meal blood sugar levels in healthy participants.
Scientific title
The effect of Thermally Oxidised Polyunsaturated fat on postprandial glycaemia in healthy participants.
Secondary ID [1] 1368 0
nil
Universal Trial Number (UTN)
Trial acronym
TOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Type 2 diabetes 256634 0
Prevention of heart disease. 256635 0
Condition category
Condition code
Metabolic and Endocrine 256796 256796 0 0
Diabetes
Cardiovascular 256797 256797 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given a test meal of 40gm dried instant mash potato reconstituted with 160ml hot water, 50gm thermally oxidised commercial sunflower oil, and 1500mg paracetamol. The paracetamol is added to enable the measurement of gastric emptying.
The thermally oxidised sunflower oil will have been prepared previously by heating the oil at 180 degrees centigrade for 6 hours and cooking potato chips from 2 potatoes every 30 minutes.
The washout period between meals is 1 week.
Intervention code [1] 255877 0
Prevention
Comparator / control treatment
The comparator is is identical to the intervention meal except that the sunflower oil is unheated (native).
Control group
Active

Outcomes
Primary outcome [1] 257681 0
Measurements of plasma glucose, insulin, C-peptide, and non-estertfied fatty acids (NEFA) will made.
Timepoint [1] 257681 0
A fasting baseline blood sample and blood samples at timepoints of 10, 20, 30 60 , 90 and 120 minutes post-prandially.
Primary outcome [2] 257765 0
Measurements of the incretin hormones glucagon-like polypeptide-1 (GLP-1), glucose-independant polypeptide (GIP) and triglycerides will also be made.
Timepoint [2] 257765 0
Baseline, 30, 60, 90 and 120 minutes.
Secondary outcome [1] 263004 0
Gastric emptying will be assesed by measurement of paracetamol in the blood after ingestion of paracetamol with the meal.
Timepoint [1] 263004 0
A fasting baseline blood sample and blood samples at timepoints of 30, 60, 90 and 120 minutes post-prandially.

Eligibility
Key inclusion criteria
*Healthy subjects
*Body mass index >18kg/m2 and <30 kg/m2
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Serious medical problems
*Use of some medications
*Fasting blood glucose > 6.1 mmol/L
*Smokers

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)
Recruitment through newspaper advertisements and then telephone screening.
The treatment schedule will be held by an independant person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised to the order of meals using the second generator for crossover trials in the www. randomisation.com website.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
19/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 2431 0
New Zealand
State/province [1] 2431 0

Funding & Sponsors
Funding source category [1] 256380 0
Charities/Societies/Foundations
Name [1] 256380 0
The National Heart Foundation of New Zealand
Country [1] 256380 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
201 Great King Street
Dunedin
9016
Country
New Zealand
Secondary sponsor category [1] 255769 0
Hospital
Name [1] 255769 0
Otago District Health Board
Address [1] 255769 0
201 Great King Street
Dunedin 9016
Country [1] 255769 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258444 0
Lower South Regional Ethics Committee
Ethics committee address [1] 258444 0
Ministry of Health
229 Moray Place
Dunedin
9016
Ethics committee country [1] 258444 0
New Zealand
Date submitted for ethics approval [1] 258444 0
Approval date [1] 258444 0
27/11/2009
Ethics approval number [1] 258444 0
LRS/09/10/045

Summary
Brief summary
The study is comparing the effect of eating meals composed of thermally oxidised and native (unheated) polyunsaturated vegtable oil and carbohydrate on normal healthy people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30740 0
Address 30740 0
Country 30740 0
Phone 30740 0
Fax 30740 0
Email 30740 0
Contact person for public queries
Name 13987 0
Dr Patrick Manning
Address 13987 0
Diabetes Department
Dunedin Hospital
201 Great King Street
Dunedin
9016
Country 13987 0
New Zealand
Phone 13987 0
+64 3 4740999
Fax 13987 0
+64 3 470 9500
Email 13987 0
patrick.manning@otagodhb.govt.nz
Contact person for scientific queries
Name 4915 0
Dr Wayne Sutherland
Address 4915 0
Department of Medical and Surgical Sciences
9th Floor
Dunedin Hospital
201 Great King Street
Dunedin
9016
Country 4915 0
New Zealand
Phone 4915 0
+64 3 4747007 ext.8512
Fax 4915 0
+64 3 4747641
Email 4915 0
Wayne.sutherland@otago.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
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Documents added automatically
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