Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000277549
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Date results information initially provided
18/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of high protein supplementation on muscle mass and function among older adults with sarcopenia
Scientific title
Efficacy of high protein supplementation on body composition and muscle function among older adults with sarcopenia: a randomized controlled trial
Secondary ID [1] 310862 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 331984 0
Condition category
Condition code
Diet and Nutrition 328726 328726 0 0
Other diet and nutrition disorders
Musculoskeletal 329381 329381 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Participants will be given oral and written instruction by principal researcher on how to consume the high protein supplementation
- Type of intervention: high protein supplements
- Serving instruction: to dissolve the said supplement in 160ml of lukewarm/cold water, stir well and consume
- Supplement content (per sachet): 174kcal, 25.1g protein (whey protein concentrate), 3.0g leucine, 10.2g carbohydrates, 3.1g fat, 2.5g fiber, 10ug vit. D3, 12mcg vit. K
- The number of times the intervention will be delivered: 2 sachets daily for 12 weeks
- Location of intervention: participant's home
- Compliance monitoring: WhatsApp text and/or call will be made to each participant once a week to ensure their compliance
Intervention code [1] 327351 0
Treatment: Other
Comparator / control treatment
- The control group will take placebo supplements at 2 sachets daily for 12 weeks.
- Participants will also be given oral and written instruction by principal researcher on how to consume the placebo supplements.
- Supplement content: 166kcal, 3.3g protein (whey permeate), 0g leucine, 3.9g fat, 26.5g carbohydrates, 5.9g fiber, 0.1ug vit D3, 0mcg vit. K
- Compliance monitoring: WhatsApp text and/or call will be made to each participant once a week to ensure their compliance
Control group
Placebo

Outcomes
Primary outcome [1] 336533 0
Body composition
Timepoint [1] 336533 0
BIA is assessed at all 3 timepoints as follows:

Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation
Primary outcome [2] 336534 0
muscle function
Timepoint [2] 336534 0
SPPB is assessed at all 3 timepoints as follows:

Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation
Primary outcome [3] 337671 0
Body composition
Timepoint [3] 337671 0
MRI is assessed during baseline and endpoint only as follows:

Baseline: week-0 of protein supplementation
Endpoint: week-12 of protein supplementation
Secondary outcome [1] 428719 0
Mid-upper arm circumference (MUAC)
Timepoint [1] 428719 0
Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation

MUAC is assessed at all 3 timepoints
Secondary outcome [2] 428720 0
mitochondrial RNA gene expression
Timepoint [2] 428720 0
Gene expression analysis is assessed during baseline and endpoint only as follows:

Baseline: week-0 of protein supplementation
Endpoint: week-12 of protein supplementation
Secondary outcome [3] 428721 0
functional performance
Timepoint [3] 428721 0
Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation

IADL is assessed at all 3 timepoints
Secondary outcome [4] 428722 0
Nutritional status
Timepoint [4] 428722 0
Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation

PG-SGA is assessed at all 3 timepoints
Secondary outcome [5] 428723 0
Quality of life
Timepoint [5] 428723 0
SAR-QOL is assessed during baseline and endpoint only as follows:

Baseline: week-0 of protein supplementation
Endpoint: week-12 of protein supplementation
Secondary outcome [6] 428724 0
Dietary intake
Timepoint [6] 428724 0
Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation

DHQ is assessed at all 3 timepoints
Secondary outcome [7] 431058 0
Mid-thigh circumference
Timepoint [7] 431058 0
Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation

Mid-thigh circumference is assessed at all 3 timepoints
Secondary outcome [8] 431059 0
Calf circumference
Timepoint [8] 431059 0
Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation

Calf circumference is assessed at all 3 timepoints
Secondary outcome [9] 431060 0
Scapular skinfold thickness
Timepoint [9] 431060 0
Baseline: week-0 of protein supplementation
Midpoint: week-6 of protein supplementation
Endpoint: week-12 of protein supplementation

Scapular skinfold thickness is assessed at all 3 timepoints

Eligibility
Key inclusion criteria
Aged 60 and above
Skeletal muscle index (SMI) <7.0kg/m2 (male) or <5.7kg/m2 (female)
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poorly controlled diabetes, chronic kidney disease stage 3a and below, gastrointestinal diseases, milk/soy intolerance or allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbers in covered box
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/12/2021
Date of last participant enrolment
Anticipated
Actual
12/07/2023
Date of last data collection
Anticipated
Actual
21/11/2023
Sample size
Target
64
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 25959 0
Malaysia
State/province [1] 25959 0
Selangor

Funding & Sponsors
Funding source category [1] 315119 0
Commercial sector/Industry
Name [1] 315119 0
UNO Nutrition Malaysia
Country [1] 315119 0
Malaysia
Primary sponsor type
Commercial sector/Industry
Name
UNO Nutrition Malaysia
Address
3A-045A, Fourth Floor, Endah Parade, Jalan 1/149E, Bandar Sri Petaling, 57000, Kuala Lumpur, Wilayah Persekutuan
Country
Malaysia
Secondary sponsor category [1] 317136 0
Commercial sector/Industry
Name [1] 317136 0
Quantum Upstream Sdn Bhd
Address [1] 317136 0
No. 66A-2, Jalan Cerdas, Taman Connaught Cheras, 56000 Kuala Lumpur, Malaysia
Country [1] 317136 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314056 0
Universiti Kebangsaan Malaysia Research Ethics Committee
Ethics committee address [1] 314056 0
Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia, Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lumpur
Ethics committee country [1] 314056 0
Malaysia
Date submitted for ethics approval [1] 314056 0
22/10/2021
Approval date [1] 314056 0
23/11/2021
Ethics approval number [1] 314056 0

Summary
Brief summary
This study aims to investigate the impact of high protein supplement (HPS) on older adults with low muscle mass and muscle function. We hypothesize that HPS consumption for 12 weeks can improve one's muscle mass (assessed using body composition analyzer and MRI) as well as muscle function (assessed through a series of physical tests), when compared to another group of participants who consume placebo supplements. Both researchers and participants will only know which supplements the latter are on after they complete the whole trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130262 0
Prof Suzana Shahar
Address 130262 0
Faculty of Health Sciences Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz 5300 Kuala Lumpur
Country 130262 0
Malaysia
Phone 130262 0
+60193326530
Fax 130262 0
Email 130262 0
suzana.shahar@ukm.edu.my
Contact person for public queries
Name 130263 0
Ms Swin Xin, Chung
Address 130263 0
Centre for Healthy Ageing & Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.
Country 130263 0
Malaysia
Phone 130263 0
+60138294861
Fax 130263 0
Email 130263 0
p112791@siswa.ukm.edu.my
Contact person for scientific queries
Name 130264 0
Ms Swin Xin, Chung
Address 130264 0
Centre for Healthy Ageing & Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.
Country 130264 0
Malaysia
Phone 130264 0
+60138294861
Fax 130264 0
Email 130264 0
p112791@siswa.ukm.edu.my

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20858Ethical approval  p112791@siswa.ukm.edu.my



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.