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Trial registered on ANZCTR


Registration number
ACTRN12610000364077
Ethics application status
Approved
Date submitted
27/04/2010
Date registered
7/05/2010
Date last updated
14/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Contribution of the level of protein hydrolysis to the effects of small intestinal protein, on gut motility, gut hormone release and sensations of appetite.
Scientific title
Contribution of the level of protein hydrolysis to the effects of intraduodenal protein, on antropyloroduodenal motility, gut hormone release and sensations of appetite in lean and obese males.
Secondary ID [1] 251681 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257247 0
Condition category
Condition code
Diet and Nutrition 257387 257387 0 0
Obesity
Oral and Gastrointestinal 257433 257433 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single, 90 minute, 3kcal/min ( 270kcal total load) intraduodenal infusion of each of the following treatments in random order: a) Intact Whey Protein, b) 18% Whey Protein Hydrosylate, or c) free amino acid solution. Appetite sensation questionnaires (VAS) and blood samples will occur at t= -15 min, 0 (start of infusion), 15, 30, 45, 60, 75, 90 & 120 (after completion of the buffet meal). A buffet meal will be provided at the end of infusion and the participant has 30 minutes to eat until comfortably full. The buffet meal consists of 300ml orange juice, 600ml water, 375ml iced coffee, 4 slices white bread, 4 slices brown bread, 100g deli leg ham, 100g virginian chicken, 4 slices cheese, 100g tomato, 100g cucumber, 100g lettuce, 2 portions manyonnaise, 2 portions margarine, 1 medium apple, 1 medium banana, 200g chocolate custard, 150g fruit salad, 200g strawberry yoghurt, and 14g milky way chocolate bar. Each volunteer will receive one of each infusion solutions on each of the 3 study days. Each study visit will be separated by no less than 3 days and no more than 10 days.
Intervention code [1] 256367 0
Treatment: Other
Comparator / control treatment
Whey protein isolate
Control group
Active

Outcomes
Primary outcome [1] 258305 0
Appetite sensations using a Visual Analogue Scale (VAS) (satiety, hunger, fullness, thirst, desire to eat and amount of food desired to eat)
Timepoint [1] 258305 0
Intubation occurs on subject arrival. At t= -15 until 0, a baseline of gastrointestinal tract (GI) motility is recorded. Infusion starts at t= 0 until 90 minutes. Extubation and buffet meal presented at 90 minutes and subject allowed to consume freely, until comfortably full, for 30 minutes (until t= 120). Blood samples and VAS questionnaire are taken at t= -15, 0, 15, 30, 45, 60, 75, 90 & 120 minutes.
Primary outcome [2] 258306 0
Gut Hormone release: cholecyctokinin (CCK), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and Ghrelin.

Gut hormone release will be assessed by Enzyme-linked Immunosorbent Assay (ELISA) from the blood samples taken.
Timepoint [2] 258306 0
Intubation occurs on subject arrival. At t= -15 until 0, a baseline of gastrointestinal tract (GI) motility is recorded. Infusion starts at t= 0 until 90 minutes. Extubation and buffet meal presented at 90 minutes and subject allowed to consume freely, until comfortably full, for 30 minutes (until t= 120). Blood samples and VAS questionnaire are taken at t= -15, 0, 15, 30, 45, 60, 75, 90 & 120 minutes.
Primary outcome [3] 258307 0
Antropyloroduodenal Motility (antropyloroduodenal pressures, number of antral, duodenal and isolated pyloric pressure waves, and basal pyloric pressure) assessed by Manometry.
Timepoint [3] 258307 0
From intubation until 90 minutes (end of infusion)
Secondary outcome [1] 264009 0
Macronutrient and total energy intake at the buffet meal will be analysed using the FoodWorks software program.
Timepoint [1] 264009 0
Buffet meal will be presented at 90 minutes when the infusion ends and the subject will be allowed to freely consume food until comfortably full for 30 minutes (until t=120 minutes).

Eligibility
Key inclusion criteria
non-obese with a Body Mass Index (BMI) of 18-25 kg/m2 and obese with a BMI of 27-35 kg/m2

Weight stable (<5% fluctuation in body weight in previous 3 months)
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant gastrointestinal symptoms, disease or surgery.
Use of prescribed or non-prescribed medications (including vitamins and herbal suppliments) which may affect energy metabolism, gastrointestinal 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)

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)
Volunteers are asked to visit the clinic for a 30 minute screening visit. A questionnaire is answered by the volunteer, based on the inclusion/exclusion criteria and eligibility is determined. A signed informed consent is obtained and study dates are established.

Eligible volunteers are assigned a subject number and randomised into a treatment for each study visit, using a randomisation table which was created on an excel spreadsheet. Randomisation involved contacting the holder (study assistant) of the randomisation table to inform them of the next subjects details and study dates. The unblinded study assistant is therefore responsible for allocating a random treatment to the subject and preparing the solution on each study day.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was generated using Microsoft Office Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
14/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2845 0
5000
Recruitment postcode(s) [2] 2855 0
5022
Recruitment postcode(s) [3] 2854 0
5025
Recruitment postcode(s) [4] 2850 0
5031
Recruitment postcode(s) [5] 2851 0
5035
Recruitment postcode(s) [6] 2846 0
5038
Recruitment postcode(s) [7] 2849 0
5042
Recruitment postcode(s) [8] 2847 0
5045
Recruitment postcode(s) [9] 2852 0
5051
Recruitment postcode(s) [10] 2848 0
5061
Recruitment postcode(s) [11] 2853 0
5068
Recruitment postcode(s) [12] 2857 0
5106
Recruitment postcode(s) [13] 2858 0
5108
Recruitment postcode(s) [14] 2856 0
5125

Funding & Sponsors
Funding source category [1] 256877 0
Government body
Name [1] 256877 0
National Health and Medical Research Council Grant
Country [1] 256877 0
Australia
Primary sponsor type
Individual
Name
Christine Feinle-Bisset
Address
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 256149 0
Individual
Name [1] 256149 0
Natalie Luscombe-Marsh
Address [1] 256149 0
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, South Australia 5000
Country [1] 256149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258883 0
Royal Adelaide Hospital Research ethics Committee
Ethics committee address [1] 258883 0
Level 3, Hanson Institute
North Terrace
Adelaide South Australia, 5000
Ethics committee country [1] 258883 0
Australia
Date submitted for ethics approval [1] 258883 0
16/10/2008
Approval date [1] 258883 0
14/01/2010
Ethics approval number [1] 258883 0
081012C

Summary
Brief summary
This study has been designed to investigate how the extent of hydrolysated protein effects gut motility, gut hormones and appetite sensations. Volunteers are required to visit the clinic on 3 occassions no less than 3 days apart. Visits will last for approximately 5 hours. A long flexible tube will be inserted through an anaesthetised nostril and passed through into the small intestine to monitor stomach and small intestinal contractions. Through this tube, a protein solution will be infused into the small intestine over a 90 minute period. Blood samples will be taken (through a cannula, which is a long flexible tube inserted into a vein) and questionnaires on appetite sensations will be completed every 15 minutes. At the end of the 90 minute solution infusion, a buffet meal will be provided. This meal will be consumed over 30 minutes until the volunteer is confortably full.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31099 0
Dr Dr Natalie Luscombe-Marsh
Address 31099 0
Royal Adelaide Hospital Level 6 Eleanor Harrald Building Frome Road, Adelaide, South Australia 5000
Country 31099 0
Australia
Phone 31099 0
+ 61 8 8222 5038
Fax 31099 0
Email 31099 0
natalie.luscombe@adelaide.edu.au
Contact person for public queries
Name 14346 0
Dr Dr Natalie Luscombe-Marsh
Address 14346 0
Royal Adelaide Hospital
Level 6 Eleanor Harrald Building
Frome Road,
Adelaide, South Australia 5000
Country 14346 0
Australia
Phone 14346 0
+61 8 8222 5038
Fax 14346 0
Email 14346 0
natalie.luscombe@adelaide.edu.au
Contact person for scientific queries
Name 5274 0
Dr Dr Natalie Luscombe-Marsh
Address 5274 0
Royal Adelaide Hospital
Level 6 Eleanor Harrald Building
Frome Road,
Adelaide, South Australia 5000
Country 5274 0
Australia
Phone 5274 0
+61 8 8222 5038
Fax 5274 0
Email 5274 0
natalie.luscombe@adelaide.edu.au

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
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