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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.
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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.
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Secondary ID [1]
251681
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
257247
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Condition category
Condition code
Diet and Nutrition
257387
257387
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0
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Obesity
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Oral and Gastrointestinal
257433
257433
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
256367
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Treatment: Other
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Comparator / control treatment
Whey protein isolate
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Control group
Active
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Outcomes
Primary outcome [1]
258305
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Appetite sensations using a Visual Analogue Scale (VAS) (satiety, hunger, fullness, thirst, desire to eat and amount of food desired to eat)
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Assessment method [1]
258305
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Timepoint [1]
258305
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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.
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Primary outcome [2]
258306
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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.
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Assessment method [2]
258306
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Timepoint [2]
258306
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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.
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Primary outcome [3]
258307
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Antropyloroduodenal Motility (antropyloroduodenal pressures, number of antral, duodenal and isolated pyloric pressure waves, and basal pyloric pressure) assessed by Manometry.
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Assessment method [3]
258307
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Timepoint [3]
258307
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From intubation until 90 minutes (end of infusion)
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Secondary outcome [1]
264009
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Macronutrient and total energy intake at the buffet meal will be analysed using the FoodWorks software program.
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Assessment method [1]
264009
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Timepoint [1]
264009
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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).
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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)
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was generated using Microsoft Office Excel.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
14/01/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
2845
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5000
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Recruitment postcode(s) [2]
2846
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5038
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Recruitment postcode(s) [3]
2847
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5045
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Recruitment postcode(s) [4]
2848
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5061
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Recruitment postcode(s) [5]
2849
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5042
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Recruitment postcode(s) [6]
2850
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5031
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Recruitment postcode(s) [7]
2851
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5035
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Recruitment postcode(s) [8]
2852
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5051
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Recruitment postcode(s) [9]
2853
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5068
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Recruitment postcode(s) [10]
2854
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5025
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Recruitment postcode(s) [11]
2855
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5022
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Recruitment postcode(s) [12]
2856
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5125
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Recruitment postcode(s) [13]
2857
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5106
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Recruitment postcode(s) [14]
2858
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5108
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council Grant
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Address [1]
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
256877
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Australia
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Primary sponsor type
Individual
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Name
Christine Feinle-Bisset
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Address
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, South Australia 5000
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Country
Australia
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Secondary sponsor category [1]
256149
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Individual
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Name [1]
256149
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Natalie Luscombe-Marsh
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Address [1]
256149
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Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, South Australia 5000
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Country [1]
256149
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
258883
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Royal Adelaide Hospital Research ethics Committee
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Ethics committee address [1]
258883
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Level 3, Hanson Institute
North Terrace
Adelaide South Australia, 5000
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Ethics committee country [1]
258883
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Australia
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Date submitted for ethics approval [1]
258883
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16/10/2008
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Approval date [1]
258883
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14/01/2010
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Ethics approval number [1]
258883
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081012C
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Dr Natalie Luscombe-Marsh
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Address
31099
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Royal Adelaide Hospital Level 6 Eleanor Harrald Building Frome Road, Adelaide, South Australia 5000
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Country
31099
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Australia
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Phone
31099
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+ 61 8 8222 5038
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Fax
31099
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Email
31099
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[email protected]
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Contact person for public queries
Name
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Dr Dr Natalie Luscombe-Marsh
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Address
14346
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Royal Adelaide Hospital
Level 6 Eleanor Harrald Building
Frome Road,
Adelaide, South Australia 5000
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Country
14346
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Australia
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Phone
14346
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+61 8 8222 5038
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Fax
14346
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Email
14346
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr Natalie Luscombe-Marsh
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Address
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Royal Adelaide Hospital
Level 6 Eleanor Harrald Building
Frome Road,
Adelaide, South Australia 5000
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Country
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Australia
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Phone
5274
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+61 8 8222 5038
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Fax
5274
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Email
5274
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[email protected]
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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.
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