Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000698178
Ethics application status
Approved
Date submitted
3/05/2019
Date registered
9/05/2019
Date last updated
17/09/2020
Date data sharing statement initially provided
9/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of nuts on the nutritional status of older Australians
Scientific title
Effects of nuts on the nutritional status of older Australians
Secondary ID [1] 298132 0
None
Universal Trial Number (UTN)
Trial acronym
NUTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 312666 0
Cardiovascular disease 312667 0
Type 2 Diabetes 312668 0
Cognitive impairment 312669 0
Frailty 312670 0
Condition category
Condition code
Diet and Nutrition 311165 311165 0 0
Other diet and nutrition disorders
Cardiovascular 311166 311166 0 0
Coronary heart disease
Metabolic and Endocrine 311167 311167 0 0
Diabetes
Neurological 311220 311220 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group in this study will consume mixed nuts butter (almond, Brazil nuts, cashews) a total of 30 grams/day, once a day as snacks (in between main meals) for 12 weeks. As the nut butter are commercially produced (chosen for quality and food safety purposes), the ratio of these three types of nuts is unknown but the nutrient composition for every 30 grams of ABC nut butter provide: 816kJ, 7.6 grams protein, 1.8 grams carbohydrate, 17.4 grams fat (1.5 grams saturated, 11 grams monounsaturated, 5 grams polyunsaturated), 1.3 grams sugar, and 1.7 grams total fibre. Compliance will be checked as the amount of unconsumed nut butter returned to researchers every week. Participants in the intervention group will be provided with all nut butter throughout this study.
Intervention code [1] 314357 0
Prevention
Comparator / control treatment
The control group in this study will resume their habitual dietary intake with no intervention.
Control group
Active

Outcomes
Primary outcome [1] 319938 0
Body weight and body composition,
Timepoint [1] 319938 0
Baseline, Week 6, Week 12

Body weight and body composition will be measured simultaneously using a leg-to-leg bio-electrical impedence scale (Tanita Inc).

Waist circumference will be measured at the midpoint between the top of hip bone and bottom of ribs using a non-stretchable tape measure.
Primary outcome [2] 319939 0
Dietary intake
Timepoint [2] 319939 0
Baseline, Week 6, Week 12

Dietary intake will assessed using 2-day food diary.
Secondary outcome [1] 369940 0
Nutritional status
Timepoint [1] 369940 0
Baseline and Week 12

Nutritional status will be assessed using a previously validated Mini Nutrition Assessment (MNA) tool.
Secondary outcome [2] 369941 0
Fasting blood triglycerides
Timepoint [2] 369941 0
Baseline and Week 12

Fasting blood sample will be collected and processed by a certified pathology service company.
Secondary outcome [3] 369942 0
Blood pressure
Timepoint [3] 369942 0
Baseline and Week 12

Blood pressure will be measured using an automated sphygmomanometer.
Secondary outcome [4] 369943 0
Physical functioning (composite)
Timepoint [4] 369943 0
Baseline and Week 12

Physical functioning will be assessed using the widely used Sit-to-Stand (time taken to repeat 5 sit-to-stand), and Timed Up-and-Go tests (time taken to stand up from a sitting position, walk a 3-meter distance, return and sit).
Secondary outcome [5] 369944 0
Cognitive function
Timepoint [5] 369944 0
Baseline and Week 12

Cognitive function will be assessed using a previously validated Montreal Cognitive Assessment (MoCA) tool.
Secondary outcome [6] 369945 0
Physical & emotional well-being and social functioning

Overall wellbeing of participants will be assessed using previously validated Short-Form 36 version 2 questionnaire that has been modified to suit the Australian population
Timepoint [6] 369945 0
Baseline and Week 12
Secondary outcome [7] 369946 0
Compliance to intervention (intervention group only)
Timepoint [7] 369946 0
Weekly during intervention

Compliance will be assessed by measuring unconsumed and returned nut butter.

Liking of nut butter and intervention will be assessed using standard 100mm visual analog scales.
Secondary outcome [8] 370081 0
Waist circumference
Timepoint [8] 370081 0
Baseline, Week 6, Week 12

Waist circumference will be measured at the midpoint between the top of hip bone and bottom of ribs using a non-stretchable tape measure.
Secondary outcome [9] 370082 0
Fasting blood glucose
Timepoint [9] 370082 0
Baseline and Week 12

Fasting blood sample will be collected and processed by a certified pathology service company.
Secondary outcome [10] 370083 0
Fasting blood insulin
Timepoint [10] 370083 0
Baseline and Week 12

Fasting blood sample will be collected and processed by a certified pathology service company.
Secondary outcome [11] 370084 0
Fasting blood high-sensitivity C-reactive protein
Timepoint [11] 370084 0
Baseline and Week 12

Fasting blood sample will be collected and processed by a certified pathology service company.
Secondary outcome [12] 370085 0
Fasting blood cholesterol including total, LDL- and HDL- cholesterol
Timepoint [12] 370085 0
Baseline and Week 12

Fasting blood sample will be collected and processed by a certified pathology service company.
Secondary outcome [13] 370086 0
Liking of intervention (intervention group only)
Timepoint [13] 370086 0
Weekly during intervention


Liking of nut butter and intervention will be assessed using standard 100mm visual analog scales.

Eligibility
Key inclusion criteria
Participants’ inclusion criteria are as follows: 1) adults aged 60 years and over, 2) both males and females, 3) absence of active illness such as gastrointestinal symptoms and are not undergoing medical treatments that affect appetite, metabolism and body weight, 4) weight stable or weight loss of <5kg in the past 3 months, and not prescribed any oral nutrition supplement by a dietitian, 5) no dementia and able to provide written consent, 6) absence of nut allergy or intolerance and willing to comply to the study intervention, 7) not regular nut consumers (consume nuts <5 times/week).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers who have nut allergy, cognitive impairment, malnourished and on nutritional intervention, have medical issues that may impact on nutritional status, and those who are not able to provide written consent will be excluded.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised based on sex and nutritional status as indicated by MNA scores (either as 'normal nutrition' or 'at risk for malnutrition', so that equal number of participants are in each study arm. Randomisation will be generated via random number generator on a computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Difference between control and intervention groups in this study will be compared using a general linear model for repeated measures ANOVA. Significant time, groups, and time-by-group effects will be determined at alpha of <0.05, two-sided. Demographic and feasibility information will be presented as descriptive statistics. Association between feasibility outcomes such as liking of nut better and dietary intake and other health and wellbeing measurements will also be performed using Pearson’s (parametric) or Spearman’s (non-parametric) correlation coefficient.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We stopped the recruitment as we have considered the eligibility of all 81 residents in the aged-care facility, where only half of them met the study eligibility criteria and only 22 interested to participate.
Date of first participant enrolment
Anticipated
13/05/2019
Actual
29/05/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
5/09/2019
Date of last data collection
Anticipated
31/12/2019
Actual
5/12/2019
Sample size
Target
48
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26368 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 302661 0
University
Name [1] 302661 0
Deakin University
Country [1] 302661 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 302591 0
Hospital
Name [1] 302591 0
McKeller Centre
Address [1] 302591 0
PO Box 281
Geelong VIC 3220
Country [1] 302591 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303284 0
Barwon Health Ethics Committee
Ethics committee address [1] 303284 0
Ethics committee country [1] 303284 0
Australia
Date submitted for ethics approval [1] 303284 0
Approval date [1] 303284 0
17/04/2019
Ethics approval number [1] 303284 0
18/248
Ethics committee name [2] 303285 0
Deakin University HREC
Ethics committee address [2] 303285 0
Ethics committee country [2] 303285 0
Australia
Date submitted for ethics approval [2] 303285 0
Approval date [2] 303285 0
03/05/2019
Ethics approval number [2] 303285 0
2019-167

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

Contacts
Principal investigator
Name 93130 0
Dr Sze Yen Tan
Address 93130 0
Deakin University
School of Exercise and Nutrition Sciences
Institute for Physical Activity and Nutrition (IPAN)
221 Burwood Highway
Burwood VIC 3125
Country 93130 0
Australia
Phone 93130 0
+61392468977
Fax 93130 0
Email 93130 0
[email protected]
Contact person for public queries
Name 93131 0
Sze Yen Tan
Address 93131 0
Deakin University
School of Exercise and Nutrition Sciences
Institute for Physical Activity and Nutrition (IPAN)
221 Burwood Highway
Burwood VIC 3125
Country 93131 0
Australia
Phone 93131 0
+61392468977
Fax 93131 0
Email 93131 0
[email protected]
Contact person for scientific queries
Name 93132 0
Sze Yen Tan
Address 93132 0
Deakin University
School of Exercise and Nutrition Sciences
Institute for Physical Activity and Nutrition (IPAN)
221 Burwood Highway
Burwood VIC 3125
Country 93132 0
Australia
Phone 93132 0
+61392468977
Fax 93132 0
Email 93132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.