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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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sarcopenia

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Musculoskeletal

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]

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]

Body composition

Timepoint [1]

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]

muscle function

Timepoint [2]

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]

Body composition

Timepoint [3]

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]

Mid-upper arm circumference (MUAC)

Timepoint [1]

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]

mitochondrial RNA gene expression

Timepoint [2]

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]

functional performance

Timepoint [3]

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]

Nutritional status

Timepoint [4]

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]

Quality of life

Timepoint [5]

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]

Dietary intake

Timepoint [6]

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]

Mid-thigh circumference

Timepoint [7]

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]

Calf circumference

Timepoint [8]

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]

Scapular skinfold thickness

Timepoint [9]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Selangor

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

UNO Nutrition Malaysia

Address [1]

3A-045A, Fourth Floor, Endah Parade, Jalan 1/149E, Bandar Sri Petaling, 57000, Kuala Lumpur, Wilayah Persekutuan

Country [1]

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]

Commercial sector/Industry

Name [1]

Quantum Upstream Sdn Bhd

Address [1]

No. 66A-2, Jalan Cerdas, Taman Connaught Cheras, 56000 Kuala Lumpur, Malaysia

Country [1]

Malaysia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Universiti Kebangsaan Malaysia Research Ethics Committee

Ethics committee address [1]

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]

Malaysia

Date submitted for ethics approval [1]

22/10/2021

Approval date [1]

23/11/2021

Ethics approval number [1]

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

Prof Suzana Shahar

Address

Faculty of Health Sciences Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz 5300 Kuala Lumpur

Country

Malaysia

Phone

+60193326530

Fax

[email protected]

Contact person for public queries

Name

Swin Xin, Chung

Address

Centre for Healthy Ageing & Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.

Country

Malaysia

Phone

+60138294861

Fax

[email protected]

Contact person for scientific queries

Name

Swin Xin, Chung

Address

Centre for Healthy Ageing & Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.

Country

Malaysia

Phone

+60138294861

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20858	Ethical approval			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically