Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000376044
Ethics application status
Approved
Date submitted
6/05/2010
Date registered
11/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Contribution of the level of protein load and duration, 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 load and duration, to the effects of intraduodenal protein, on antropyloroduodenal motility, gut hormone release and sensations of appetite in lean and obese males.
Secondary ID [1] 251687 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257295 0
Condition category
Condition code
Diet and Nutrition 257444 257444 0 0
Obesity
Oral and Gastrointestinal 257445 257445 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single 60 minute intraduodenal infusion at 4mL/min of:
a) 0 kcal/min (control of saline solution )
b) 0.5 kcal/min (Whey Protein Hydrolysate)
c) 1.5 kcal/min (Whey Protein Hydrolysate)
d) 3.0 kcal/min (Whey Protein Hydrolysate)

Appetite sensation questionnaires in the form of a Visual Analogue Scale (VAS), blood samples.

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 mayonnaise, 2 portions margarine, 1 medium apple, 1 medium banana, 200g chocolate custard, 150g fruit salad, 200g strawberry yoghurt, and a 14g milky way chocolate bar.

Each volunteer will receive one of each infusion solutions on each of the 4 study days. Each study visit will be separated by no less than 3 days. Each study visit will last approximately 3-6 hours.
Intervention code [1] 256428 0
Other interventions
Comparator / control treatment
Placebo: A single, 60 minute, 0kcal/min intaduodenal infusion of saline solution.
Control group
Placebo

Outcomes
Primary outcome [1] 258362 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] 258362 0
Intubation occurs on subject arrival.

At t= -10 until 0, a baseline of the gastrointestinal (GI) tract motility is recorded.

Infusion starts at t= 0 until 60 minutes.

Extubation and buffet meal presented at 60 minutes and subject allowed to consume freely, until comfortably full, for 30 minutes (until t= 90).

Blood samples and VAS questionnaire are taken at t= -10, 0, 15, 30, 45, 60, & 90 minutes.
Primary outcome [2] 258363 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 (ELIZA) from the blood samples taken.
Timepoint [2] 258363 0
Intubation occurs on subject arrival.

At t= -10 until 0, a baseline of GI tract motility is recorded.

Infusion starts at t= 0 until 60 minutes.

Extubation and buffet meal presented at 60 minutes and subject allowed to consume freely, until comfortably full, for 30 minutes (until t= 90).

Blood samples and VAS questionnaire are taken at t= -10, 0, 15, 30, 45, 60, & 90 minutes.
Primary outcome [3] 258364 0
Antropyloroduodenal Motility (antropyloroduodenal pressures, number of antral, duodenal and isolated pyloric pressure waves, and basal pyloric pressure) assessed by Manometry.
Timepoint [3] 258364 0
From intubation until 60 minutes end of infusion
Secondary outcome [1] 264098 0
Macronutrient and total energy intake at the buffet meal will be analysed using the FoodWorks software program.
Timepoint [1] 264098 0
Buffet meal will be presented at 60 minutes when the infusion ends and the subject will be allowed to freely consume food until comfortably full for 30 minutes (until t=90 minutes).

Eligibility
Key inclusion criteria
non-obese with a Body Mass Index (BMI) of 18-25kg/m2 and obese with a BMI of 27-35kg/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 effect 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 eligibilty is determined. A signed informed consent form 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 subject's 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
Recruiting
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] 2866 0
5000
Recruitment postcode(s) [2] 2873 0
5006
Recruitment postcode(s) [3] 2872 0
5008
Recruitment postcode(s) [4] 2870 0
5037
Recruitment postcode(s) [5] 2869 0
5038
Recruitment postcode(s) [6] 2867 0
5043
Recruitment postcode(s) [7] 2871 0
5045
Recruitment postcode(s) [8] 2868 0
5061

Funding & Sponsors
Funding source category [1] 256918 0
Government body
Name [1] 256918 0
National Health and Medical Research Council Grant
Country [1] 256918 0
Australia
Primary sponsor type
Individual
Name
Dr Natalie Luscombe-Marsh
Address
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 256187 0
University
Name [1] 256187 0
University of Adelaide
Address [1] 256187 0
North Terrace
Adelaide, SA 5005
Country [1] 256187 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258924 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 258924 0
Level 3, Hanson Institute, North Terrace,
Adelaide, South Australia, 5000
Ethics committee country [1] 258924 0
Australia
Date submitted for ethics approval [1] 258924 0
16/10/2008
Approval date [1] 258924 0
14/01/2010
Ethics approval number [1] 258924 0
081012e

Summary
Brief summary
This study has been designed to investigate how the load and duration of Whey Protein Hydrolysate effects gut motility, gut hormones, and appetite sensations.

Volunteers are required to visit the clinic on 4 occassions no less than 3 days apart. Visits will last for approximately 5 hours.

A long felxible tube will be inserted through an anaethetised nostril and passed through into the small intestine to monitor stomach and small intestinal contractions. Through this tube, a whey protein or saline solution will be infused over a 60 minute period (4mL/min). 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 60 minute infusion, a buffet meal will be provided. This meal will be consumed over 30 minutes until the volunteer is comfortably full.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31129 0
Address 31129 0
Country 31129 0
Phone 31129 0
Fax 31129 0
Email 31129 0
Contact person for public queries
Name 14376 0
Dr Natalie Luscombe-Marsh
Address 14376 0
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, South Australia 5000
Country 14376 0
Australia
Phone 14376 0
+61 8 8222 5038
Fax 14376 0
Email 14376 0
natalie.luscombe@adelaide.edu.au
Contact person for scientific queries
Name 5304 0
Dr Natalie Luscombe-Marsh
Address 5304 0
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, South Australia 5000
Country 5304 0
Australia
Phone 5304 0
+61 8 8222 5038
Fax 5304 0
Email 5304 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
SourceTitleYear of PublicationDOI
EmbasePlasma free amino acid responses to intraduodenal whey protein, and relationships with insulin, glucagon-like peptide-1 and Energy intake in lean healthy men.2016https://dx.doi.org/10.3390/nu8010004
N.B. These documents automatically identified may not have been verified by the study sponsor.