Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000949280
Ethics application status
Approved
Date submitted
3/11/2009
Date registered
4/11/2009
Date last updated
27/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative effects of intraduodenal macronutrients, carbohydrate, lipid and protein, and combinations of lipid and protein, on gut motility, hormones, appetite and energy intake in lean subjects
Scientific title
Comparative effects of intraduodenal macronutrients, carbohydrate, lipid and protein, and combinations of lipid and protein, on antropyloroduodenal motility, gut hormones, appetite and energy intake in lean subjects
Secondary ID [1] 262681 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To compare in healthy, lean individuals the effects of the three macronutrients, carbohydrate, protein and fat, on antropyloroduodenal motility, gut hormone release, appetite and energy intake. 252106 0
To compare in healthy, lean individuals the effects of combinations of lipid and protein,
on antropyloroduodenal motility, gut hormone release, appetite and energy intake. 252107 0
Condition category
Condition code
Oral and Gastrointestinal 252312 252312 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study 1 and Study 2 will be conducted seperately and consist of different volunteers.
Subjects within each study will undergo 5 treatments, in double-blind, randomised, cross over fashion. Gastrointestinal (GI) motility, hormone release, appetite and energy intake will be evaluated. The nutrient infusions will be administered for 120 min at a rate of 3 kcal/min, corresponding to the average rate of postprandial gastric emptying treatments. Treatments within each study will be separated by 7-10 days.

Study 1 will evalutate:
i) lipid
ii) carbohydrate
iii) protein
iv) macronutrient combination of lipid:carbohydrate:protein (30:50:20)
v) saline control

Study 2 will evaluate:
i) lipid
ii) protein
iii) protein:lipid (2:1)
iv) protein:lipid (1:2)
v) saline control
Intervention code [1] 241496 0
Lifestyle
Comparator / control treatment
Saline
Control group
Placebo

Outcomes
Primary outcome [1] 253183 0
Antropyloroduodenal motility - During the 120 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 (Flexisoft)
Timepoint [1] 253183 0
-15, 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes
Secondary outcome [1] 262110 0
Appetite and hunger - Using visual analogue scale questionnaires
Timepoint [1] 262110 0
-15, 0, 15, 30, 45, 60, 75, 90, 120 and 150 minutes
Secondary outcome [2] 262111 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 [2] 262111 0
-15, 0, 15, 30, 45, 60, 75, 90, 120 and 150 minutes
Secondary outcome [3] 262112 0
Energy intake - At t = 120 min the infusion will be discontinued, and the subject extubated and offered a cold buffet-style meal (t = 120 - 150 min). The meal will be weighted before and after consumption to for the assessment of energy intake using Foodwork
Timepoint [3] 262112 0
120 minutes

Eligibility
Key inclusion criteria
Subjects will all be healthy males between age 18 -55 years, with a body mass index (BMI) of 18 - 25 kg/m2. Subjects will be 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each subject will be questioned prior to the study to exclude:
(1) significant GI symptoms; disease or surgery
(2) current use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
(3) diabetes mellitus
(4) individuals with low blood iron levels
(5) epilepsy
(6) cardiovascular or respiratory disease
(7) any other significant illness as assessed by the investigator
(8) allergy to local anaesthetic
(9) intake of > 20 g alcohol on a daily basis
(10) smokers (cigarettes/cigars/marijuana)
(11) unrestrained eaters, as determined by a score of =12 on the eating restraint questionnaire component of the eating questionnaire.

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. Concealment allocation was not used in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2009
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)

Funding & Sponsors
Funding source category [1] 243962 0
Self funded/Unfunded
Name [1] 243962 0
A/Prof Christine Feinle-Bisset
Country [1] 243962 0
Australia
Primary sponsor type
Individual
Name
A/Prof Christine Feinle-Bisset
Address
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 251316 0
Individual
Name [1] 251316 0
Dr Natalie Luscombe-Marsh
Address [1] 251316 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country [1] 251316 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244073 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 244073 0
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Ethics committee country [1] 244073 0
Australia
Date submitted for ethics approval [1] 244073 0
05/10/2009
Approval date [1] 244073 0
22/10/2009
Ethics approval number [1] 244073 0
091013

Summary
Brief summary
To compare in healthy, lean individuals the effects of
(1) the three macronutrients, carbohydrate, protein and fat,
(2) combinations of lipid and protein,
on antropyloroduodenal motility, gut hormone release, appetite and energy intake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30457 0
Address 30457 0
Country 30457 0
Phone 30457 0
Fax 30457 0
Email 30457 0
Contact person for public queries
Name 13704 0
Radhika Seimon
Address 13704 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 13704 0
Australia
Phone 13704 0
+61 8 8222 5039
Fax 13704 0
+61 8 8223 3870
Email 13704 0
radhika.seimon@adelaide.edu.au
Contact person for scientific queries
Name 4632 0
Radhika Seimon
Address 4632 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 4632 0
Australia
Phone 4632 0
+61 8 8222 5039
Fax 4632 0
+61 8 8223 3870
Email 4632 0
radhika.seimon@adelaide.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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