Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000557235
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
8/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is there a relationship between sensitivity to fat in the mouth and gastrointestinal tract, and is sensitivity to fat different in obesity?
Scientific title
A comparison of antropyloroduodenal motility, hormone release, appetite and energy intake after a 90 minute infusion of fat versus saline in lean and obese males
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 237173 0
Condition category
Condition code
Diet and Nutrition 237496 237496 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects received a 90 minute intraduodenal infusion of fat (C18:1) delivered at 0.78kcal per minute (70Kj total) and saline, at a rate of 2ml/ min (180ml total). Treatments were separated by 3-14 days, and all subjects received both treatments.
Intervention code [1] 236884 0
Lifestyle
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238307 0
During the 90 minute infusion antropyloduodenal motility was assessed via changes in the pressures within specific portion of the gastrointestinal tract (antrum, pylorus and duodenum) which was captured by sensors on the catheter, and connected to a computer-based system, running commercially available hardware (Oakdale Flexisoft)
Timepoint [1] 238307 0
-10, 0, 15,30,45,60,75 and 90 minutes
Primary outcome [2] 238308 0
Appetite and hunger
Timepoint [2] 238308 0
-10, 0, 15,30,45,60,75, 90 and 120 minutes
Primary outcome [3] 238309 0
Hormone release cholecystokinin (CCK) and Peptide YY (PYY). Blood samples were drawn from subjects every 15 minutes until t=90, and then once more at t=120. Radioimmuno assays were used to determine the concentration of these hormones in plasma.
Timepoint [3] 238309 0
-10, 0, 15,30,45,60,75, 90 and 120 minutes
Primary outcome [4] 238310 0
Taste sensitivity to fat
Timepoint [4] 238310 0
Taste thresholds were determined by 3 ascending forced choice procedure, during a third test day, ie it was on a separate day than either the fat or saline infusion
Primary outcome [5] 238311 0
Habitual energy and fat intake
Timepoint [5] 238311 0
A 2 day diet recall and fat intake questionnaire were recorded on the same day as threshold testing.
Secondary outcome [1] 244701 0
lipase activity
Timepoint [1] 244701 0
Saliva was collected from all subjects on the same day as threshold testing. Lipase activity was quantified using a colorometric lipase assay.
Secondary outcome [2] 244702 0
taste sensitivity to n-6-propylthiouracil
Timepoint [2] 244702 0
Filter papers containing n-6-propylthiouracil (PROP) were provided to all subjects on the same day as threshold testing.

Eligibility
Key inclusion criteria
Subjects had to be males between the ages of 18 -55 years, with a body mass index (BMI) between 18 -35 kg/m2). Subjects were required to be unrestrained eaters, consume less than 20g of alcohol per week, be non-smokers, free of gastrointestinal or chronic disease and not currently taking medication whicfunction.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Restrained eaters, smokers, sufferers of gastrointestinal or chronic disease, individuals currently on medication known to affect appetite or gastrointestinal function. Subjects completed factor 1 of the 3 factor eating questionnaire (restrained eaters are defined as those who score higher than 12), subjects were asked about their personal and familial medical history relating to chronic illness (heart disease and cancer) as well as gastrointestinal disease, ie Crohns, Irritable Bowel Syndrome. Subjects were asked if they were smokers, and how much alcohol they consumed on a weekly basis.

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)
Subjects were recruited via newspaper advertisement or flyers which were posted in the local paper (Adelaide Advertiser), displayed within the University of Adelaide and the Royal Adelaide Hospital, or dropped into the letterboxes of residents living within the surrounding suburbs. As all subjects received both treatments, concealment allocation was not used in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin flipping.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1880 0
5000
Recruitment postcode(s) [2] 1881 0
5034
Recruitment postcode(s) [3] 1882 0
5035

Funding & Sponsors
Funding source category [1] 237278 0
Government body
Name [1] 237278 0
University of Adelaide
Country [1] 237278 0
Australia
Funding source category [2] 237279 0
Government body
Name [2] 237279 0
Commonwealth Scientific and Industrial Research Organisation
Country [2] 237279 0
Australia
Funding source category [3] 237292 0
University
Name [3] 237292 0
Deakin University
Country [3] 237292 0
Australia
Primary sponsor type
Individual
Name
Christine Feinle-Bisset
Address
University of Adelaide,
Royal Adelaide Hospital,
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, 5000
South Australia,
Australia
Country
Australia
Secondary sponsor category [1] 236765 0
Individual
Name [1] 236765 0
Russell Keast
Address [1] 236765 0
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, 3125
Victoria
Australia
Country [1] 236765 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239377 0
Royal Adelaide Hospital Ethics Conmitee
Ethics committee address [1] 239377 0
Ethics committee country [1] 239377 0
Australia
Date submitted for ethics approval [1] 239377 0
18/11/2008
Approval date [1] 239377 0
19/12/2008
Ethics approval number [1] 239377 0
081217

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

Contacts
Principal investigator
Name 29858 0
Address 29858 0
Country 29858 0
Phone 29858 0
Fax 29858 0
Email 29858 0
Contact person for public queries
Name 13105 0
Christine Feinle-Bisset
Address 13105 0
University of Adelaide,
Royal Adelaide Hospital
Level 6 Eleanor Harrald Building
From Road, Adelaide 5000
South Australia
Country 13105 0
Australia
Phone 13105 0
+618 8222 5247
Fax 13105 0
+618 8223 3870
Email 13105 0
[email protected]
Contact person for scientific queries
Name 4033 0
Christine Feinle-Bisset
Address 4033 0
University of Adelaide,
Royal Adelaide Hospital
Level 6 Eleanor Harrald Building
From Road, Adelaide 5000
South Australia
Country 4033 0
Australia
Phone 4033 0
+618 8222 5247
Fax 4033 0
+618 8223 3870
Email 4033 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.