Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000542291
Ethics application status
Approved
Date submitted
15/12/2008
Date registered
6/07/2009
Date last updated
6/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of fat consumption on postprandial blood glycemic, insulinemic and incretin responses in healthy volunteers.
Scientific title
Effect of fat consumption on postprandial blood glycemic, insulinemic and incretin responses in healthy volunteers
Secondary ID [1] 283528 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycemic response to foods. 4129 0
Prevention and management of both type 1 and type 2 diabetes. 237142 0
Condition category
Condition code
Diet and Nutrition 4298 4298 0 0
Other diet and nutrition disorders
Diet and Nutrition 4326 4326 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Using standard Glycemic Index (GI) testing methodology, 10 volunteers, over 6 randomised occasions, (1 week between visits) will ingest 3 glucose reference drinks (50 g glucose) and 3 flat-bread meals differing in fat content (5, 15 and 30% - 3.44, 10.33 and 20.66 g respectively) after an overnight fast. The flat-bread meals are labelled with 13C octanoic acid (1microlitre/g food). Baseline and postprandial measures of blood glucose, insulin and satiety hormones, as well as measures of gastric-emptying rate via breath-test will be taken.
Intervention code [1] 236820 0
Not applicable
Comparator / control treatment
Postprandial responses to the flat-bread meals are expressed as a percentage of the responses to the glucose reference drinks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 238230 0
Attenuation of glycemic response with increased fat dose.
Timepoint [1] 238230 0
Fasting then blood samples at 15, 30, 45, 60, 90, 120 and 180mins postprandial
Secondary outcome [1] 244563 0
Increased satiety hormone responses with increased fat dose.
Timepoint [1] 244563 0
Fasting then 15, 30, 45, 60, 90, 120 and 180 mins samples postprandial.

Eligibility
Key inclusion criteria
Healthy volunteers between the ages of 18 and 60.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of diabetes, or other metabolic diseases known to impact on glycemic control.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2009
Actual
14/11/2008
Date of last participant enrolment
Anticipated
Actual
12/12/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4292 0
Government body
Name [1] 4292 0
Food Futures, Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition, New Zealand Institute for Plant and Food Research Ltd.
Country [1] 4292 0
Australia
Primary sponsor type
Government body
Name
Food Futures CSIRO Human Nutrition
Address
Gate 13 Kintore Avenue, Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 3865 0
Government body
Name [1] 3865 0
New Zealand Institute for Plant and Food Research Ltd.
Address [1] 3865 0
New Zealand Institute for Plant and Food Research Ltd. Private Bag 11 600, Palmerston North, New Zealand
Country [1] 3865 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6317 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 6317 0
Ethics committee country [1] 6317 0
Australia
Date submitted for ethics approval [1] 6317 0
Approval date [1] 6317 0
23/10/2008
Ethics approval number [1] 6317 0
08/09

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

Contacts
Principal investigator
Name 35024 0
Dr Tony Bird
Address 35024 0
CSIRO Human Nutrition Gate 13 Kintore Avenue Adelaide SA 5000
Country 35024 0
Australia
Phone 35024 0
+61 8 83038902
Fax 35024 0
Email 35024 0
+61 8 83038902
Contact person for public queries
Name 12371 0
Tony Bird
Address 12371 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue Adelaide SA 5000
Country 12371 0
Australia
Phone 12371 0
+61 8 83038902
Fax 12371 0
Email 12371 0
[email protected]
Contact person for scientific queries
Name 3299 0
Dr Tony Bird
Address 3299 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue Adelaide SA 5000
Country 3299 0
Australia
Phone 3299 0
+61 8 83038902
Fax 3299 0
Email 3299 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.