Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000091404p
Ethics application status
Submitted, not yet approved
Date submitted
9/01/2025
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the impacts of nutritional education to help in the treatment of age-related muscle loss
Scientific title
Understanding the translational impact of nutrition education to treat sarcopenia in participants aged 60 -80 years old
Secondary ID [1] 313630 0
None
Universal Trial Number (UTN)
U1111-1317-3084
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia (loss of skeletal muscle mass and function with age) 336188 0
Condition category
Condition code
Musculoskeletal 332724 332724 0 0
Other muscular and skeletal disorders
Diet and Nutrition 332725 332725 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be invited to the Swinburne campus on three separate occasions to undertake the different aspects of the research project:
• Visit 1 (~1 hour in duration):
- Sign study consent forms and provide research team Medical Clearance form from participant's GP
- Sign Exercise and Sports Science Australia (ESSA) Adult Pre-Exercise Screening System form for exercise clearance
- Complete Protein Knowledge and Sarcopenia Awareness questionnaires
- Complete questionnaires of self-reported physical activity, activities of daily living, and health-related quality of life
- Undertake sarcopenia diagnostic testing including maximum handgrip strength, body composition measurement (muscle mass and body fat), and a Short Physical Performance Battery consisting of gait speed, chair stand test, and balance.

• Visit 2 (1 week after visit 1; ~1 hour in duration):
- Complete current habitual diet questionnaire
- Attend the professional education session on protein nutrition and exercise for promoting skeletal muscle health
- Provide participants the ‘Muscle Matters: Preventing Sarcopenia with Lifestyle Changes’ educational resource manual that has been designed by the research team specifically for this study.

• Visit 3 (3 months after visit 1; ~1 hour in duration):
- Complete Protein Knowledge and Sarcopenia Awareness questionnaires
- Complete questionnaires of self-reported physical activity, activities of daily living, and health-related quality of life
- Complete current habitual diet questionnaire
- Undertake sarcopenia Diagnostic testing including maximum handgrip strength, body composition measurement (muscle mass and body fat), and a Short Physical Performance Battery consisting of gait speed, chair stand test, and balance.

All study visits will be supervised and co-conducted by Dr. Donny Camera (over 15 years research in skeletal muscle health involving exercise and nutrition), Dr. Stephen Keenan (Accredited Practicing Dietitian with over 5 years nutrition research) and Jennifer (Accredited Practicing Dietitian with over 10 years nutrition research).

Attendance at each of the three visits will be recorded by the research team. Adherence to the information provided to the participants within the resource booklet between Visits 2 and 3 will not be directly measured by the research team. This is on purpose to allow participants to naturally include aspects of the information in the resource booklet into their habitual lifestyle. Measures obtained in Visit 3 will provide the research team some indication as to whether, and to what extent, participants have adhered to information within the resource booklet.
Intervention code [1] 330222 0
Behaviour
Intervention code [2] 330329 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340289 0
Dietary Protein Knowledge
Timepoint [1] 340289 0
Baseline (Visit 1) and Post-Intervention (Visit 3, 3 months after Visit 1)
Secondary outcome [1] 443632 0
Muscle Strength
Timepoint [1] 443632 0
Baseline (Visit 1) and post-intervention (Visit 3, 3 months after Visit 1)
Secondary outcome [2] 443633 0
Skeletal muscle function
Timepoint [2] 443633 0
Pre (Visit 1) and Post (Visit 3, 3 months after Visit 1)
Secondary outcome [3] 443631 0
Skeletal muscle (lean body) mass
Timepoint [3] 443631 0
Pre (Visit 1) and Post (Visit 3, 3 months after Visit 1)

Eligibility
Key inclusion criteria
• Aged between 60-80 years.
• Community-dwelling (i.e.: not living in an aged-care facility, etc)
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Being aged <60 years or >80 years of age,
(2) Inability to stand unaided,
(3) Acute or terminal illness likely to compromise exercise participation,
(4) Unstable or ongoing cardiovascular/respiratory disorder,
(5) Musculoskeletal or neurological disease or functional limitations disrupting voluntary movement or that might have limited training
(7) Inability to commit to the study and its requirement.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to the explorative nature of this proposal, there is no sample size power calculation. A mixed model ANOVA with repeated measures will be performed including the baseline value in the outcome vector and fixed factor for time (pre, one-week and three-month post).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/03/2025
Actual
Date of last participant enrolment
Anticipated
18/09/2026
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318100 0
University
Name [1] 318100 0
Swinburne University
Country [1] 318100 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
Country
Australia
Secondary sponsor category [1] 320505 0
None
Name [1] 320505 0
Address [1] 320505 0
Country [1] 320505 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316745 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 316745 0
Ethics committee country [1] 316745 0
Australia
Date submitted for ethics approval [1] 316745 0
31/08/2024
Approval date [1] 316745 0
Ethics approval number [1] 316745 0

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

Contacts
Principal investigator
Name 138874 0
Dr Donny Camera
Address 138874 0
Swinburne University; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 138874 0
Australia
Phone 138874 0
+61 403166127
Fax 138874 0
Email 138874 0
[email protected]
Contact person for public queries
Name 138875 0
Donny Camera
Address 138875 0
Swinburne University; Building SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 138875 0
Australia
Phone 138875 0
+61 403166127
Fax 138875 0
Email 138875 0
[email protected]
Contact person for scientific queries
Name 138876 0
Donny Camera
Address 138876 0
Swinburne University; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 138876 0
Australia
Phone 138876 0
+61 403166127
Fax 138876 0
Email 138876 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
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.