Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000906853
Ethics application status
Approved
Date submitted
23/08/2012
Date registered
27/08/2012
Date last updated
11/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of protein on gut motility and hormones, and appetite and energy intake in healthy older individuals
Scientific title
Effects of intraduodenal protein load, on energy intake, appetite, antropyloroduodenal motility, amino acids, hormones and glucose in healthy older individuals
Secondary ID [1] 281081 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 287231 0
Condition category
Condition code
Diet and Nutrition 287554 287554 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 287555 287555 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
i) 0 kcal/min (saline control)
ii) 0.5 kcal/min (Whey Protein Hydrolysate)
iii) 1.5 kcal/min (Whey Protein Hydrolysate)
iv) 3 kcal/min (Whey Protein Hydrolysate)
in 16 older subjects

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

A standard buffet meal will be provided at the end of the 60 minute infusion from which the volunteer 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 bar.

Each volunteer will receive one of each infusion solution over 4 study days. Each study visit will be seperated by no less than 3 days.

Each study visit will last approximately 3-6 hours.
Intervention code [1] 285535 0
Prevention
Comparator / control treatment
Volunteers will act as their own control via administration of a single 0kcal/min intraduodenal infusion of saline solution, delivered at a rate of 4mL/min for 60 minutes, to enable comparison to nutrient containing infusions.
Control group
Placebo

Outcomes
Primary outcome [1] 287806 0
Antropyloroduodenal motility (antropyloroduodenal pressures; number of antral, duodenal and isolated pyloric pressure waves; basal pyloric pressure) assessed by Manometry.
Timepoint [1] 287806 0
Intubation occurs on subject arrival.

At t= -15 until 0, a baseline of the antropyloroduodenal (APD) motility is recorded.

Infusion starts at t=0 until t=60 minutes. APD motility is assessed continuously for the duration of the infusion (t=0-60 minutes).

Subject is extubated at t=60 minutes.
Primary outcome [2] 287807 0
Plasma concentrations of gut hormones (cholecyctokinin (CKK), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), gastric inhibitory polypeptide (GIP), ghrelin, glucagon and insulin), glucose and amino acids.
Timepoint [2] 287807 0
Blood samples are taken at t= 0, 15, 30, 45 and 60 minutes.
Primary outcome [3] 287808 0
Macronutrient and total energy intake of a standard buffet meal are quantified using Foodworks software.
Timepoint [3] 287808 0
Buffet meal will be presented at the end of the infusion and after extubation (t=60). The subject will be allowed to freely consume food for 30 minutes until comfortably full (until t=90).
Secondary outcome [1] 298865 0
Appetite sensations using a Visual Analogue Scale (VAS) (nausea, hunger, fullness, desire to eat, thirst).
Timepoint [1] 298865 0
VAS questionnaires are given at t= 0, 15, 30, 45, 60 and 90 minutes.
Secondary outcome [2] 298866 0
Blood pressure and heart rate are determined using an automatic sphygmomanometer.
Timepoint [2] 298866 0
Blood pressure and heart rate are measured at t= 0, 15, 30, 45, 60 and 90 minutes.

Eligibility
Key inclusion criteria
Body Mass Index (BMI): 20-30 kg/m2

Weight stable (<5% fluctuation in body weight in previous 3 months).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant gastrointestinal symptoms, disease, or surgery.

Current gallbladder or pancreatic disease; diabetes mellitus; epilepsy; cardiovasculr or respiratory diseases; any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above).

Impaired cognitive function.

Depression.

Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may effect gastrointestinal function or appetite.

Lactose intolerant or other food allergies; intolerance or allergy to paracetomol.

Individuals with low ferritin levels or who have donated blood in the 12 weeks prior to taking part in the study.

Current intake of >2 standard drinks on >5 days per week.

Current smokers of cigarettes/cigars/marijuana.

Current intake of any illicit substance.

Experience claustrophobia in confined spaces.

Unable to tolerate nasogastrointestinal tube, or to comprehend study protocol.

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)
Volunteers are asked to visit the clinic for a screening visit. A series of screening questionnaires are answered by the volunteer, and a blood sample is taken for determination of ferritin levels. Eligibility is determined based on the inclusion/exclusion criteria. 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 created on an excel spreadsheet. Randomisation involves contacting the holder of the randomisation table (study assistant) to inform them of the subjects details and study dates. The unblinded study assistant is therefore responsible for allocating a random treatment to the subject and preparing the solution for infusion on each study day.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was created 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
Completed
Date of first participant enrolment
Anticipated
3/09/2012
Actual
7/09/2012
Date of last participant enrolment
Anticipated
Actual
18/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285864 0
Government body
Name [1] 285864 0
National Health and Medical Research Council Grant
Country [1] 285864 0
Australia
Primary sponsor type
Individual
Name
Dr Stijn Soenen
Address
Level 6 Eleanor Harrald Building,
Frome Road,
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 284687 0
University
Name [1] 284687 0
University of Adelaide
Address [1] 284687 0
North Terrace
Adelaide, SA 5005
Country [1] 284687 0
Australia
Secondary sponsor category [2] 284688 0
Hospital
Name [2] 284688 0
Royal Adelaide Hospital
Address [2] 284688 0
North Terrace
Adelaide, SA 5005
Country [2] 284688 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287893 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 287893 0
Ethics committee country [1] 287893 0
Australia
Date submitted for ethics approval [1] 287893 0
Approval date [1] 287893 0
01/05/2012
Ethics approval number [1] 287893 0
120504

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

Contacts
Principal investigator
Name 34610 0
Dr Stijn Soenen
Address 34610 0
Discipline of Medicine, University of Adelaide
attn.: Dr Stijn Soenen
Level 6, Eleanor Harrald Building,
Frome Road,
Adelaide, SA 5000
Country 34610 0
Australia
Phone 34610 0
+61 8 8313 3638
Fax 34610 0
Email 34610 0
[email protected]
Contact person for public queries
Name 17857 0
Stijn Soenen
Address 17857 0
Discipline of Medicine, University of Adelaide
attn.: Dr Stijn Soenen
Level 6, Eleanor Harrald Building,
Frome Road,
Adelaide, SA 5000
Country 17857 0
Australia
Phone 17857 0
+61 8 8313 3638
Fax 17857 0
+61 8 8223 3870
Email 17857 0
[email protected]
Contact person for scientific queries
Name 8785 0
Stijn Soenen
Address 8785 0
Discipline of Medicine, University of Adelaide
attn.: Dr Stijn Soenen
Level 6, Eleanor Harrald Building,
Frome Road,
Adelaide, SA 5000
Country 8785 0
Australia
Phone 8785 0
+61 8 8313 3638
Fax 8785 0
+61 8 8223 3870
Email 8785 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
SourceTitleYear of PublicationDOI
EmbaseDose-dependent effects of randomized intraduodenal whey-protein loads on glucose, gut hormone, and amino acid concentrations in healthy older and younger men.2018https://dx.doi.org/10.3390/nu10010078
N.B. These documents automatically identified may not have been verified by the study sponsor.