Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000699864
Ethics application status
Approved
Date submitted
28/04/2021
Date registered
7/06/2021
Date last updated
13/05/2022
Date data sharing statement initially provided
7/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of nut butter supplementation in older adults
Scientific title
Feasibility of nut butter supplementation for health of older adults
Secondary ID [1] 304076 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 321736 0
Cardiovascular disease 321737 0
Type 2 diabetes mellitus 321738 0
Frailty 321739 0
Condition category
Condition code
Diet and Nutrition 319477 319477 0 0
Other diet and nutrition disorders
Cardiovascular 319478 319478 0 0
Other cardiovascular diseases
Metabolic and Endocrine 319479 319479 0 0
Diabetes
Musculoskeletal 319792 319792 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group in this study will consume 30g peanut butter every day for 12 weeks. The peanut butter are commercially produced and pre-packaged into 30g sachets. The nutrient composition for every 30 grams of peanut butter provide: 746kJ, 8g protein, 4.3g carbohydrate, 14.3g total fat (1.9g as saturated fat and remaining unsaturated fat), 1.8g sugar, and 2.3g total fibre. Participants in the intervention group will be provided with all nut butter throughout this study. Compliance will be determined by the amount of unconsumed peanut butter sachets returned to the researchers.
Intervention code [1] 320408 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] 327354 0
Compliance to intervention (intervention group only)
Timepoint [1] 327354 0
12 weeks post-intervention commencement

Compliance will be assessed by measuring unconsumed and returned peanut butter.
Primary outcome [2] 327655 0
Perception of intervention (intervention group only)
Timepoint [2] 327655 0
12 weeks post-intervention commencement

Perception of intervention foods will be assessed using standard 100mm visual analog scales as well as likert scales
Secondary outcome [1] 394685 0
Body weight
Timepoint [1] 394685 0
Baseline and 12 weeks post-intervention commencement

Body weight will be measured simultaneously using a leg-to-leg bio-electrical impedence scale (Tanita Inc).
Secondary outcome [2] 394686 0
Dietary intake
Timepoint [2] 394686 0
Baseline and 12 weeks post-intervention commencement

Dietary intake will assessed using 2-day food diary
Secondary outcome [3] 394687 0
Fasting blood triglycerides
Timepoint [3] 394687 0
Baseline and 12 weeks post-intervention commencement

Fasting blood sample will be collected and processed by a certified clinical pathology service.
Secondary outcome [4] 394688 0
Fasting blood glucose
Timepoint [4] 394688 0
Baseline and 12 weeks post-intervention commencement

Fasting blood sample will be collected and processed by a certified clinical pathology service.
Secondary outcome [5] 394689 0
Fasting blood insulin
Timepoint [5] 394689 0
Baseline and 12 weeks post-intervention commencement

Fasting blood sample will be collected and processed by a certified clinical pathology service.
Secondary outcome [6] 394690 0
Fasting blood cholesterols (total, LDL, HDL)
Timepoint [6] 394690 0
Baseline and 12 weeks post-intervention commencement

Fasting blood sample will be collected and processed by a certified clinical pathology service.
Secondary outcome [7] 394691 0
Fasting blood high-sensitivity c-reactive protein
Timepoint [7] 394691 0
Baseline and 12 weeks post-intervention commencement

Fasting blood sample will be collected and processed by a certified clinical pathology service.
Secondary outcome [8] 394692 0
Blood pressure
Timepoint [8] 394692 0
Baseline and 12 weeks post-intervention commencement

Blood pressure will be measured using an automated sphygmomanometer
Secondary outcome [9] 394693 0
Physical functioning
Timepoint [9] 394693 0
Baseline and 12 weeks post-intervention commencement

Physical functioning will be assessed using the widely used 1) Sit-to-Stand (number of sit & stands performed in 30 seconds), 2) Timed Up-and-Go tests (time taken to stand up from a sitting position, walk a 3-meter distance, return and sit).
Secondary outcome [10] 396104 0
Muscle strength
Timepoint [10] 396104 0
Baseline and 12 weeks post-intervention commencement

Muscle strength will be measured using the knee-extensor muscle strength test on the dominant leg.
Secondary outcome [11] 396105 0
Body fat percentage
Timepoint [11] 396105 0
Baseline and 12 weeks post-intervention commencement

Body fat percentage will be measured simultaneously using a leg-to-leg bio-electrical impedence scale (Tanita Inc).
Secondary outcome [12] 396106 0
Waist circumference)
Timepoint [12] 396106 0
Baseline and 12 weeks post-intervention commencement

Waist circumference will be measured at the midpoint between the top of hip bone and bottom of ribs using a non-stretchable tape measure.

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 supplements, 5) 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 undergoing nutritional interventions, have medical issues that require treament, 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 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
Completed
Date of first participant enrolment
Anticipated
1/07/2021
Actual
9/07/2021
Date of last participant enrolment
Anticipated
30/09/2021
Actual
6/12/2021
Date of last data collection
Anticipated
14/01/2022
Actual
8/03/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 34283 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 308460 0
University
Name [1] 308460 0
Deakin University
Country [1] 308460 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 309304 0
None
Name [1] 309304 0
Address [1] 309304 0
Country [1] 309304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308416 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 308416 0
Ethics committee country [1] 308416 0
Australia
Date submitted for ethics approval [1] 308416 0
12/03/2021
Approval date [1] 308416 0
04/06/2021
Ethics approval number [1] 308416 0
2021-100

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

Contacts
Principal investigator
Name 110638 0
Dr Sze-Yen Tan
Address 110638 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway
Burwood VIC 3125
Country 110638 0
Australia
Phone 110638 0
+61 392468977
Fax 110638 0
Email 110638 0
[email protected]
Contact person for public queries
Name 110639 0
Sze-Yen Tan
Address 110639 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway
Burwood VIC 3125
Country 110639 0
Australia
Phone 110639 0
+61 392468977
Fax 110639 0
Email 110639 0
[email protected]
Contact person for scientific queries
Name 110640 0
Sze-Yen Tan
Address 110640 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway
Burwood VIC 3125
Country 110640 0
Australia
Phone 110640 0
+61 392468977
Fax 110640 0
Email 110640 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.