Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001291774
Ethics application status
Approved
Date submitted
28/09/2022
Date registered
4/10/2022
Date last updated
2/06/2024
Date data sharing statement initially provided
4/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Capacity of Older Individuals after Nut Supplementation (COINS) Study
Scientific title
Investigating the effect of peanut butter on older adults’ physical and cognitive capacity
Secondary ID [1] 308060 0
None
Universal Trial Number (UTN)
Trial acronym
COINS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical dysfunction 327751 0
Cognitive dysfunction 327752 0
Condition category
Condition code
Diet and Nutrition 324823 324823 0 0
Other diet and nutrition disorders
Musculoskeletal 324866 324866 0 0
Normal musculoskeletal and cartilage development and function
Neurological 324867 324867 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the peanut butter intervention group will be asked to consume 43g of pre-portioned, commercially available peanut butter per day over the 6 month intervention period (provided to participants free-of-charge). Adherence to intervention will be monitored through the return of un-consumed peanut butter portions.
Intervention code [1] 324508 0
Treatment: Other
Intervention code [2] 324549 0
Prevention
Comparator / control treatment
Participants in the control group will be asked to continue with their habitual dietary and physical activity patterns throughout the study (no intervention).
Control group
Active

Outcomes
Primary outcome [1] 332642 0
Walking speed using timed up-and-go test
Timepoint [1] 332642 0
Baseline and 6-months post-intervention commencement
Primary outcome [2] 334957 0
Walking speed using the 6 meter walk test
Timepoint [2] 334957 0
Baseline and 6-months post-intervention commencement
Secondary outcome [1] 414185 0
Dynamic balance and coordination using the Four Square Step Test
Timepoint [1] 414185 0
Baseline and 6-months post-intervention commencement
Secondary outcome [2] 414186 0
Lean mass using the Dual energy X-ray Absorptiometry (DXA) method
Timepoint [2] 414186 0
Baseline and 6-months post-intervention commencement
Secondary outcome [3] 414187 0
Upper extremity hand grip strength using a dynamometer
Timepoint [3] 414187 0
Baseline and 6-months post-intervention commencement
Secondary outcome [4] 414189 0
Lower extremity strength using the 30-second Sit-To-Stand Test
Timepoint [4] 414189 0
Baseline and 6-months post-intervention commencement
Secondary outcome [5] 414190 0
Lower extremity strength using the 5 Sit-To-Stand Test
Timepoint [5] 414190 0
Baseline and 6-months post-intervention commencement
Secondary outcome [6] 414192 0
Lower extremity isometric knee extensor muscle strength with a dynamometer
Timepoint [6] 414192 0
Baseline and 6-months post-intervention commencement
Secondary outcome [7] 414193 0
Late-life function & disability using the 16-item Late-Life Function & Disability Instrument (Late-Life FDI)
Timepoint [7] 414193 0
Baseline and 6-months post-intervention commencement
Secondary outcome [8] 414194 0
Late-life function & disability using the Modified Falls Efficacy Scale (MFES)
Timepoint [8] 414194 0
Baseline and 6-months post-intervention commencement
Secondary outcome [9] 414195 0
Risk of sarcopenia using the validated 5-question SARC-F questionnaire
Timepoint [9] 414195 0
Baseline and 6-months post-intervention commencement
Secondary outcome [10] 414196 0
Cognitive function using the Trail Making Test
Timepoint [10] 414196 0
Baseline and 6-months post-intervention commencement
Secondary outcome [11] 414197 0
Cognitive function using the Montreal Cognitive Assessment or The MoCA Test
Timepoint [11] 414197 0
Baseline and 6-months post-intervention commencement
Secondary outcome [12] 414198 0
Dietary intake and diet quality assessed as a composite secondary outcome using a 3-day food record method
Timepoint [12] 414198 0
Baseline and 6-months post-intervention commencement
Secondary outcome [13] 414200 0
Nutrition status using Mini Nutrition Assessment (MNA) full form
Timepoint [13] 414200 0
Baseline and 6-months post-intervention commencement
Secondary outcome [14] 414201 0
Weight using a digital weighing scale
Timepoint [14] 414201 0
Baseline and 6-months post-intervention commencement
Secondary outcome [15] 414202 0
Height using a stadiometer
Timepoint [15] 414202 0
Baseline and 6-months post-intervention commencement
Secondary outcome [16] 414203 0
Waist circumference using a tape measure
Timepoint [16] 414203 0
Baseline and 6-months post-intervention commencement
Secondary outcome [17] 414204 0
Whole body composition using a bioelectrical impedance method
Timepoint [17] 414204 0
Baseline and 6-months post-intervention commencement
Secondary outcome [18] 414205 0
Physical Activity level using the Physical Activity Scale for the Elderly (PASE)
Timepoint [18] 414205 0
Baseline and 6-months post-intervention commencement
Secondary outcome [19] 414206 0
Compliance to intervention in the intervention group by counting un-consumed peanut butter portions
Timepoint [19] 414206 0
6-months post-intervention commencement
Secondary outcome [20] 414207 0
Participants’ perception (as a composite outcome) to the appearance, smell, taste, flavour, texture, aftertaste, overall pleasantness, and ease of intervention in the intervention group only using standard 100mm visual analog scales anchored at 0 (dislike extremely), 50 (neither like or dislike), and 100 (like extremely)
Timepoint [20] 414207 0
3-months and 6-months post-intervention commencement
Secondary outcome [21] 414356 0
Nutrition status using Short Nutritional Assessment Questionnaire (SNAQ)
Timepoint [21] 414356 0
Baseline and 6-months post-intervention commencement
Secondary outcome [22] 422541 0
Balance using the Standing Balance Test
Timepoint [22] 422541 0
Baseline and 6-months post-intervention commencement
Secondary outcome [23] 422542 0
Telomere length using cheek buccal epithelial cells
Timepoint [23] 422542 0
Baseline and 6-months post-intervention commencement

Eligibility
Key inclusion criteria
The inclusion criteria include: 1) BMI 18 – 35 kgm-2, 2) absence of nut allergy, 3) low nut consumers (2 or less serves of any nuts/week), 4) generally healthy or with metabolic disease(s) managed through lifestyle or common medications (except for insulin), 5) at risk for functional impairment, as defined as feeling unsteady on feet when standing/ walking/doing daily activities, or have had a fall in the last 12 months, or have concerns over decreased appetite and poor dietary intake.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria include: 1) taking any other oral nutrition supplement or undertaking structure resistance or exercise programs more than once per week, 2) presence of illness that affects dietary intake, metabolism or cognitive/physical function capacity e.g. gastrointestinal disease, musculoskeletal conditions or cancer, and 3) presence of conditions (e.g. osteoarthritis or lower back pain) that prevent participants from performing physical capacity tests in this study.

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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised based on age, sex and BMI so that equal number of participants are in each study arm. Randomisation will be generated via random number generator on a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size justification: No previous clinical study using nuts with physical capacity or function & disability as an outcome are available. Thus, the calculation of sample size is based on a recent trial that used an oral nutrition supplement (ONS) to improve older adults’ physical capacity. The PB used in this study has comparable energy and protein content to the ONS (ONS: 231 kcal & 8.6g protein per 55g; PB:176 kcal & 9.2g protein per 30g), hence likely to produce a similar effect size. Since agility was consistently reported to be associated with nut intake in previous observational studies, this proposal is powered based on the walking speed of older adults, which improved by an average of 0.15m/s after ONS. This expected improvement in walking speed is consistent with the previously reported minimally clinically important difference (0.05 – 0.12 m/s). Based on expected improvement of 0.15 m/s, Australian population’s walking speed SD of 0.2 m/s,34 allowable difference between intervention arms of 0.05 m/s, and attrition rate of 15%, 60 participants per group (total sample size of 120) will be recruited for this clinical trial.

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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
29/05/2023
Date of last participant enrolment
Anticipated
14/06/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
120
Accrual to date
114
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38599 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 312317 0
Commercial sector/Industry
Name [1] 312317 0
The Peanut Institute Foundation
Country [1] 312317 0
United States of America
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 313870 0
None
Name [1] 313870 0
Address [1] 313870 0
Country [1] 313870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311685 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 311685 0
221 Burwood Highway, Burwood VIC 3125
Ethics committee country [1] 311685 0
Australia
Date submitted for ethics approval [1] 311685 0
28/10/2022
Approval date [1] 311685 0
10/05/2023
Ethics approval number [1] 311685 0
2022-279

Summary
Brief summary
The primary objective is to investigate the effects of peanut butter (43g/d), consumed for 6 months, on 1) older adults’ functional capacity (primary outcomes) and its associated factors such as cognitive function, lean mass, muscle strength, as well as late-life function and disability, which reflects real-world endpoint related to physical capacity.

The secondary objective is to explore if the effects of peanut butter supplementation on primary objective outcomes are mediated by improvement in diet quality following peanut butter supplementation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121990 0
Dr Sze Yen Tan
Address 121990 0
Deakin University Institute for Physical Activity and Nutrition 221 Burwood Highway Burwood VIC 3125
Country 121990 0
Australia
Phone 121990 0
+61392468977
Fax 121990 0
Email 121990 0
szeyen.tan@deakin.edu.au
Contact person for public queries
Name 121991 0
Dr Sze Yen Tan
Address 121991 0
Deakin University Institute for Physical Activity and Nutrition 221 Burwood Highway Burwood VIC 3125
Country 121991 0
Australia
Phone 121991 0
+61392468977
Fax 121991 0
Email 121991 0
szeyen.tan@deakin.edu.au
Contact person for scientific queries
Name 121992 0
Dr Sze Yen Tan
Address 121992 0
Deakin University Institute for Physical Activity and Nutrition 221 Burwood Highway Burwood VIC 3125
Country 121992 0
Australia
Phone 121992 0
+61392468977
Fax 121992 0
Email 121992 0
szeyen.tan@deakin.edu.au

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


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.