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Trial registered on ANZCTR


Registration number
ACTRN12612000956808
Ethics application status
Approved
Date submitted
5/09/2012
Date registered
6/09/2012
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of protein on gastric emptying and hormones, and appetite and energy intake in undernourished compared with healthy older individuals
Scientific title
Effects of oral protein on energy intake, appetite, antral area, gastric emptying, amino acids, hormones and glucose in undernourished compared with healthy older individuals
Secondary ID [1] 281174 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 287342 0
Condition category
Condition code
Diet and Nutrition 287678 287678 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 287679 287679 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participant receives a single 450mL preload per study visit (separated by at least 3 days) in a randomised, crossover fashion of: i) 30 grams Whey Protein Isolate with diet lime cordial flavouring or ii) Water control with diet lime cordial flavouring. Both preloads contain 100uL of 13C Octanoic acid to enable measurement of gastric emptying via 13CO2 in the breath.

Gastric emptying rate and intragastric meal distribution are determined using 3D ultrasound.

Appetite sensation questionnaires in the form of a Visual Analogue Scale (VAS) are measured and blood samples are collected for concentrations of gut hormones, amino acids and glucose.

A standard buffet meal is provided at 180 minutes following the preload 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 bar.

Each volunteer receives one of each of the 2 treatments on each of the 2 study days. Each study visit is separated by no less than 3 days. Each visit lasts approximately 4 hours.
Intervention code [1] 285624 0
Treatment: Other
Intervention code [2] 285625 0
Prevention
Comparator / control treatment
Placebo: a single 450mL water and diet lime cordial preload.

Undernourished older people will be compared to 'healthy' older people.
Control group
Placebo

Outcomes
Primary outcome [1] 287921 0
Macronutrient and total energy intake of a standard buffet meal are quantified using Foodworks software.
Timepoint [1] 287921 0
Buffet meal is presented at 180 minutes following the last ultrasound measurement and the subject is allowed to freely consume food until comfortably full for 30 minutes (until t= 210 minutes)
Primary outcome [2] 287922 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] 287922 0
Blood samples are taken at t= -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes.
Primary outcome [3] 287923 0
Gastric emptying rate assessed by three-dimensional (3D) ultrasonography and 13C Octanoic Acid Breath Test.

3D ultrasound defines the fraction of the meal emptied from the stomach, including 50% emptying time (T1/2), during the study.

The 13C Octanoic Acid breath test assesses gastric emptying of the protein drink through measurement of 13CO2 in the breath via mass spectrometry. Half-emptying time and gastric emptying coefficient will also be calculated and compared to those obtained using 3D ultrasonography.
Timepoint [3] 287923 0
Ultrasound measurements for assessment of gastric emptying will be taken at -15, 0, and every 15 minutes thereafter until 180 minutes.

Breath samples are collected for assessment of 13CO2 immediately before meal ingestion, and every 5 minutes for the 30 minutes following meal ingestion. Breath samples are then collected every 15 minutes until 180 minutes.
Secondary outcome [1] 299058 0
Appetite sensations using a Visual Analogue Scale (VAS) (nausea, hunger, fullness, desire to eat, thirst).
Timepoint [1] 299058 0
VAS is administered at time points: -15 minutes, 0 minutes and every fifteen minutes thereafter until 180 minutes. The final VAS is administered at 210 minutes after the buffet meal has been consumed.
Secondary outcome [2] 299059 0
Blood pressure and heart rate are determined using an automatic sphygmomanometer.
Timepoint [2] 299059 0
Blood pressure and heart rate are measured at -15 minutes, 0 minutes and every fifteen minutes thereafter until 180 minutes. The final measurement is at 210 minutes after the buffet meal has been consumed.

Eligibility
Key inclusion criteria
Undernourished older people:

at risk of malnourishment + malnourishment defined by a well validated, widely used, screening tool that is associated with poor outcomes in older people: the Mini Nutritional Assessment (MNA) with a score <24 out of 30

and, at least one of: self-reported weight loss in the previous 3 months, or a Body Mass Index (BMI) <22 kg/m2

'Healthy' older people:

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 comprehend study protocol.

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 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. 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 preload on each study day.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was created using http://www.randomization.com/
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
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
17/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285947 0
Government body
Name [1] 285947 0
National Health and Medical Research Council Grant
Country [1] 285947 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] 284770 0
University
Name [1] 284770 0
University of Adelaide
Address [1] 284770 0
North Terrace
Adelaide, SA 5005
Country [1] 284770 0
Australia
Secondary sponsor category [2] 284771 0
Hospital
Name [2] 284771 0
Royal Adelaide Hospital
Address [2] 284771 0
North Terrace
Adelaide, SA 5005
Country [2] 284771 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287981 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 287981 0
Ethics committee country [1] 287981 0
Australia
Date submitted for ethics approval [1] 287981 0
Approval date [1] 287981 0
01/06/2012
Ethics approval number [1] 287981 0
120602

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

Contacts
Principal investigator
Name 34671 0
Dr Stijn Soenen
Address 34671 0
Dr Stijn Soenen
Adelaide Health & Medical Sciences Building, level 5
Cnr North Tce & George St
Adelaide, SA, 5000
Country 34671 0
Australia
Phone 34671 0
+61 8 8313 3638
Fax 34671 0
Email 34671 0
stijn.soenen@adelaide.edu.au
Contact person for public queries
Name 17918 0
Dr Stijn Soenen
Address 17918 0
Dr Stijn Soenen
Adelaide Health & Medical Sciences Building, level 5
Cnr North Tce & George St
Adelaide, SA, 5000
Country 17918 0
Australia
Phone 17918 0
+61 8 8313 3638
Fax 17918 0
+61 8 8313 7794
Email 17918 0
stijn.soenen@adelaide.edu.au
Contact person for scientific queries
Name 8846 0
Dr Stijn Soenen
Address 8846 0
Dr Stijn Soenen
Adelaide Health & Medical Sciences Building, level 5
Cnr North Tce & George St
Adelaide, SA, 5000
Country 8846 0
Australia
Phone 8846 0
+61 8 8313 3638
Fax 8846 0
+61 8 8313 7794
Email 8846 0
stijn.soenen@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

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