Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000585527
Ethics application status
Approved
Date submitted
14/05/2015
Date registered
4/06/2015
Date last updated
4/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of pork on cognitive function and strength of community-living older adults: a quasi experimental trial
Scientific title
The impact of 12-week provision of pork, compared to chicken-containing meals on cognitive function and strength in community-living older Australians
Secondary ID [1] 286705 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 295061 0
Physical functioning 295062 0
Condition category
Condition code
Diet and Nutrition 295314 295314 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Residents aged 60+ years from lifestyle aged care facilities will receive a dietary pork intervention for 12 weeks. Facilities rather than individuals are randomised (quasi-experimental design). Meals are prepared by a commercial kitchen that supplies the aged care facilities, before being frozen and delivered to participants at their homes once a week. Participants are instructed to continue with their usual diets but to substitute four meals per week with the provided meals. The four meals can be consumed at any meal time on any four days within a week.

Recipes for all provided meals were collected from the commercial caterer (Flagstaff Fine Foods). All recipes were analysed using FoodWorks dietary analysis software (Xyris Software 2009). Average nutritional content of meals provided was compared between pork and chicken groups.

Nutritional content of provided meals (mean (SD)), by diet group is as follows:

Pork meals:
Energy 1528 (530) kJ; Protein 28.1 (6.3)g; Fat 8.8 (6.1)g;
Saturated fat 3.6 (3.3)g; Carbohydrate 40.3 (19.4)g; Sugars 8.5 (2.9)g; Sodium 739 (393)mg.

Chicken meals:
Energy 1661 (346) kJ; Protein 25.2 (6.2) g; Fat 14.3 (2.9)g; Saturated fat 4.6 (1.8)g; Carbohydrate 38.2 (17.5)g; Sugars 8.2 (5.9)g; Sodium 752 (318)mg.

Actual meal choices that were provided are shown below:
Pork meals:
Pork in BBQ sauce
Roast pork & gravy
Ham & cheese omelette
Pork and apple cranberry
Ham steak with pineapple glaze
Chicken meals:
Honey soy chicken
Roast chicken & gravy
Chicken Schnitzel
Curry chicken
Chicken & asparagus mornay

Adherence with the intervention was assessed using a self-completed food diary for 3 consecutive days (one weekend, 2 weekdays) at baseline, week 6 and week 12. Food intake data was analysed using FoodWorks using the NUTTAB 2010, Ausfoods 2012 and Ausbrands 2012 database (Xyris Software, Highgate Hill, GLD, Australia, Version 6, 2009). Participants also completed a weekly checklist of number of provided meals that were consumed.
Intervention code [1] 291853 0
Lifestyle
Intervention code [2] 291925 0
Prevention
Comparator / control treatment
Chicken-containing meals, matched as closely as possible for macronutrient content.
Control group
Placebo

Outcomes
Primary outcome [1] 295050 0
Cognition: A battery of cognitive tasks will be used to assess specific domains of mental functioning.
a. The Geriatric Depression scale, a 15-item questionnaire, will assess changes in mood.
b. The Rey Auditory Verbal Learning test (RAVLT) measured verbal learning and memory. It requires the participant to learn a list of words over 5 presentation-test trial sequences.
c. The Serial ordered pointing task is a test of working memory that requires the participant to point to a picture or pattern on each page of a booklet that contains the same pictures in different arrangements.
d. The Boston naming task assesses word-retrieval difficulty in the participants, which is related to semantic memory. The participant is asked to name a series of objects.
e. The verbal fluency task is a sensitive measure of executive dysfunction and control processes. The task requires the participant to produce as many words starting with a particular letter as possible in one minute.
f. Trail-making task (TMT) requires the participant to join a series of dots labelled with consecutive numbers or with alternating letters and numbers. It is a measure of executive function.
g. Digit-span backwards task requires the participant to recall a small set of digits in reverse order and assesses short-term memory storage and executive control processes.
Timepoint [1] 295050 0
6 weeks and 12 weeks
Primary outcome [2] 295051 0
2. Strength:
a. Maximal upper body strength (kg) measured using a hand dynamometer (Model Jamar Plus, Sammsons Preston Rolyan, Bolingbrook, IL, USA) while the subject is seated, arm adducted and elbow at a 90 degree angle. Participants exert maximal force once using each hand.
b. The 30-second sit-to-stand test to measure lower body strength. Participants perform as many full chair stands in a 30-second period as they are able to, with folded arms across their chest.
c. A timed ‘get up and go’ task to measure dynamic balance performing three common functional activities such as standing up from a chair and walking and turning through the evaluation of mobility. Participants are required to stand up from the chair, walk 3m at a comfortable speed, turn around and walk back to the chair and sit down. The time taken to complete this task is recorded.
d. The Six Minute Walk Test as a measure of functional exercise performance. This test required the participants to walk a 10m course at a comfortable speed for 6 minutes using walking frames or aids normally used for daily life if required. The numbers of laps completed during the 6 minutes is tallied to calculate the total distance in meters walked.
Timepoint [2] 295051 0
6 weeks and 12 weeks
Secondary outcome [1] 314672 0
Dietary intake, measured by asking participants to keep a food diary for 3 consecutive days (one weekend, 2 weekdays) at baseline, week 6 and week 12 of the intervention. Food intake data will be analysed with the FoodWorks programme, using the NUTTAB 2010, Ausfoods 2012 and Ausbrands 2012 database (Xyris Software, Highgate Hill, GLD, Australia, Version 6, 2009).
Timepoint [1] 314672 0
6 weeks and 12 weeks
Secondary outcome [2] 314673 0
Nutritional status: Mini-Nutritional Assessment (MNA) is a validated 18-item questionnaire designed for use in persons aged 65y+that includes four domains, including anthropometric status, dietary patterns, mobility, living conditions and global self-view of health. A score >23.5 of a possible 30 indicates that the individual has no risk of malnutrition; a score between 17- 23.5 indicates that the individual is at risk of malnutrition, and < 17 indicates overt malnutrition.
Timepoint [2] 314673 0
6 weeks and 12 weeks

Eligibility
Key inclusion criteria
Relatively healthy older people aged 60 years and older with no serious cognitive impairment that lived in independent-living (lifestyle) facilities of one Retirement Trust in regional New South Wales (NSW). Participants were recruited via mail-drops with an invitation
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Uncontrolled hypertension, unstable Type 1 diabetes, food allergies, vegetarianism, physical disability that limited walking ability, severe dementia and/or dysphasia. These criteria were selected as they would either impact on ability and willingness to consume the provided meat-containing meals (food allergies, vegetarianism, dysphasia), or affect ability to perform the outcome indicator tests (severe dementia, physical disability that limited walking ability).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Flyers advertising the trial were delivered to residents from the 10 lifestyle residential care villages within the Illawarra region of New South Wales, Australia, in April 2014, inviting interested parties to attend an information session about the study.

All consenting participants were randomly assigned by cluster (e.g. retirement village) to minimise the potential contamination between the two diet groups and also enhance feasibility of fieldwork.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation and assignment of clusters was conducted by a biostatistician with the use of a computer generated randomisation of the study numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Quasi-experimental (facilities not indivduals within each retirement facility randomised to either pork or chicken groups)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be conducted, adjusting for physical activity (fixed for baseline measures) and reported dietary intake of energy and protein (variable by time point).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
3/07/2014
Date of last participant enrolment
Anticipated
1/09/2014
Actual
1/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9674 0
2517 - Woonona
Recruitment postcode(s) [2] 9675 0
2518 - Corrimal
Recruitment postcode(s) [3] 9676 0
2518 - Tarrawanna
Recruitment postcode(s) [4] 9677 0
2518 - Towradgi
Recruitment postcode(s) [5] 9678 0
2517 - Woonona East

Funding & Sponsors
Funding source category [1] 291270 0
Commercial sector/Industry
Name [1] 291270 0
Pork CRC Innovation Grant
Country [1] 291270 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue
Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 289943 0
Other Collaborative groups
Name [1] 289943 0
Illawarra Retirement Trust
Address [1] 289943 0
IRT Group
Level 3, 77 Market Street,
Wollongong NSW 2500

PO Box 2106,
Wollongong DC NSW 2500
Country [1] 289943 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292830 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 292830 0
Ethics committee country [1] 292830 0
Australia
Date submitted for ethics approval [1] 292830 0
Approval date [1] 292830 0
20/03/2013
Ethics approval number [1] 292830 0
HE12/446

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

Contacts
Principal investigator
Name 57214 0
A/Prof Karen Charlton
Address 57214 0
School of Medicine
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 57214 0
Australia
Phone 57214 0
+62-242214754
Fax 57214 0
Email 57214 0
[email protected]
Contact person for public queries
Name 57215 0
Karen Charlton
Address 57215 0
School of Medicine
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 57215 0
Australia
Phone 57215 0
+61-2-42214754
Fax 57215 0
Email 57215 0
[email protected]
Contact person for scientific queries
Name 57216 0
Karen Charlton
Address 57216 0
School of Medicine
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 57216 0
Australia
Phone 57216 0
+61-2-42214754
Fax 57216 0
Email 57216 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
No additional documents have been identified.