The goal of this randomized clinical trial is to study the effectiveness of protein
supplements in frailty improvement, muscle strength, physical performance, energy intake
and body composition of pre-frail elderly people. in Selangor, Malaysia.

The main question[s] it aims to answer are:

Does PS intervention significantly affect in frailty improvement, muscle strength,
physical performance, energy intake and body composition of elderly people? For the
interventional group, Participants will receive 30g of SUSTINEX Hydrolyzed Whey Protein.
The participants will be asked to add it to their food or drinks to reach the goal of
consuming 30g daily. For control group, participants will receive no intervention- usual
care, will receive the standard care of the clinic without supplemented with PS.

Effectiveness of Protein Supplementation on Frailty Improvement, Muscle Strength and Physical Performance Among Pre-Frail Elderly People

Frailty

Muscle Weakness

Physical Dependence

Weight Loss

Several studies stated that an increase in dietary protein consumption may help to
prevent muscle loss and stimulate muscle protein synthesis. This study aims to study the
effectiveness of protein supplements in frailty improvement, muscle strength, physical
performance, energy intake and body composition of pre-frail elderly people. This study
is a 3-months (12 weeks), single blind, parallel randomized controlled experiment with
two arms in which outpatient persons in Serdang hospitals, Malaysia, are randomly
assigned to one of two arms: a) control group (CG), and b) protein (PSG) supplementation
in two of Selangor hospital's outpatients (Serdang Hospital, Hospital Pengajar UPM)
Serdang, Malaysia. Study population are men or women elderlies who 60 years or more and
classified (according to Fried criteria) as pre-frail older adults.

Sample size was calculated based on the findings of (Shahar et al., 2019), considering a
mean ± SD of BMI in protein supplement study as 25.91 ± 2.96 kg/m2 in the placebo group
and 23.82 ± 4.16 kg in protein supplement group, with a power of 80% and an α level
(2-tailed) of 5%. This process conducted using G Software. This gave a sample size of 17
participants/group and total 34 participants. With an expected dropout rate of 20%, a
sample size of 20 participants/group is considered adequate.

  -  Participants will be recruited from outpatient and Dietetics clinics patients who
     will be screened by the site investigators in both Serdang and HPUPM hospital using
     FRAIL Screen and demographic and health-related information will be collected.

  -  An information papers will be given and discussed following the invitation
     procedure. Individuals who agree to participate will be asked to submit written
     informed permission and will then be screened to determine their eligibility to
     participate. Individuals who have been assessed as eligible to participate will be
     invited to a pre-intervention data collection session (baseline assessment).

  -  After testing the eligibility, a random sequence will be generated for the patients'
     numbers which results in a sequence of random numbers divided in two groups.

  -  The allocation ratio is 1:1. To guarantee allocation concealment, the randomization
     will be carried out by an independent third party. The envelope will be opened on
     the spot, deciding which group the participant would be allocated to either Group 1
     (PSG): Intervention Group or Group 2 (CG): Control Group.

Protein Supplement Group:

Participants will receive 30g of SUSTINEX Hydrolysed Whey Protein. The participants will
be asked to add it to their soft food or their beverages to reach the goal of consuming
30g daily.

Control Group (CG) Receive no intervention- usual care, will receive the standard care of
the clinic without supplemented with PS.

• Before entering the run-in period, the participants will be interviewed using a
structured questionnaire to obtain information: Demographic data of participants,
anthropometric measurements, practice function/performance, muscle strength activities,
dietary intake (3-day food record) will all be done one week prior to the intervention
period in order to get the baseline data.

Interventional group:

  -  All participants will be instructed on how to prepare and consume the protein
     supplements and how to record them in the provided compliance diaries.

  -  The supplement will be in powder form in individual sachets (15g per sachet) and
     subjects will be asked to mix 2 sachets daily in their soft foods or beverages (1
     sachet in the morning & 1 sachet in the evening).

Supplements Supplying:

• Supplements will be handed to the participants in the dietetic clinic at the beginning
of the trial and in the middle (6th week) of the trial and they will be asked to return
the previous can in order to check the retain sachets.

Monitoring Process:

  -  Compliance diaries will be handed out to participants with instructions provided on
     how to complete them; specifically, they will be asked to record the timing and
     number of supplements consumed per day.

  -  The researcher will check compliance with the supplements prescription on a weekly-
     basis message reminder sent to each participant.

  -  According to the remained sachets and the dairies, if the study team identify that a
     participant's compliance to the planned number of protein sachets, is less than 70%,
     the researcher will respectively interview the participant to assess any
     difficulties and identify strategies that could facilitate compliance.

Follow-up Process:

  -  Participants should not take any over-the-counter medications without informing the
     researcher. They can continue taking the prescribed medications by their respective
     physicians.

  -  Adverse events (AEs), that is, any untoward medical occurrences will be investigated
     during all visits, whether or not they are related to the study product. The events
     will be reviewed by the study's investigator and participants will be referred to
     the research physician as required.

Data analysis The research design is structured on two assessments which involves the
baseline and after the intervention. The characteristics of the baseline respondents (CG,
PSG) will be reported. Missing data at random (MAR) method will be used treat data that
are missing during intervention by way of intention to treat (ITT) as recommended by
Dziura, Post, Zhao, Fu, & Peduzzi (2013).

Categorical variables will be summarized by frequencies and percentages, continuous
variables will be summarized by means and standard deviation. Additionally, cross
tabulation of the categorical variables will be done to verify the independency of some
required variables targeted in the research objectives which will be verify via
chi-square test or Fisher's exact test.

The continuous data will further be examined for conformity to normality distribution
assumptions, the continuous data with non-normality characteristics will be summarized by
the median (IQR). Non-parametric statistical methodology such as Mann Whitney, Wilcoxon
signed rank test among other statistical methodologies will be adopted accordingly for
non normal continuous variables.

Analysis of variance (ANOVA) on repeated measures for the second factor will be used to
assess variability in weight loss, exhaustion, weakness, slowness and low activity
between the baseline and intervention. Analysis of covariance (ANCOVA) via generalized
linear model will be adopted for the post-intervention analysis. The sensitivity analysis
will be examined through receiver operating characteristics (ROC) curves especially on
variables that has missing data.

SUSTINEX Hydrolyzed Whey Protein

Effectiveness of Protein Supplementation on Frailty Improvement, Muscle Strength and Physical Performance Among Pre-Frail Elderly People in Selangor- Malaysia: A Randomized Clinical Study

To study the change of frailty phenotypes (Weight loss/ shrinking - Exhaustion - Weakness
- Slowness - Low activity) will be measured according to Fried Criteria using report
sheet ≥ 3 frailty Criteria = Frail

1 - 2 frailty Criteria = Pre-frail 0 frailty Criteria = Normal.

Body weight, lean body mass, total body fat (TBF), and muscle mass will be measured to
the nearest 0.1 kg using whole-body dual-energy X-ray absorptiometry DXA and a portable
body composition analyzer (OMRON HBF-375, Japan).

BMI will be calculated as the body mass in kilograms divided by the square of the height
in meters. Standing height (±1.0 cm) will be measured using a wall stadiometer.

Balance tests comprises the duration of each of side-by-side stand, semitandem stand, and
tandem stand; the duration of each stand is 10 seconds, if the participant can hold this
duration, 1 point will be awarded, except for the tandem stand, which is worth 2 points
for this duration.

The gait speed test is the time to complete a 4-meter walk (repeated 3 times); the score
for this test is graded from 0 to 4; 0 means the participant was unable to do the walk,
and 4 means the time taken to complete the 4-meter walk was less than 4.8 seconds.

The sit-to-stand test is the time to rise from sitting (repeated 5 times),the score will
be graded from 0 to 4; 0 means the participant was unable to complete 5 chair stands or
complete stands in more than 60 seconds, and 4 means the chair stand time is 11.19
seconds or less.

The SPPB consists of balance, gait speed, and sit-to-stand ability. A 0- to 12-point
scale is used to score the sum of the three assessments, with higher point values
corresponding with greater levels of physical function and lower disability, whereas
lower point values correspond with lower levels of physical function and higher
disability, respectively.

Handgrip strength will be measured by Hand dynamometer

Three-day weighed food diaries will be collected at baseline, and postintervention and
will be reviewed by the dietitian for completeness. Three-day food diaries will be
analyzed using Nutritionist Pro commercial software (version 4.1 Axxya Systems, Stafford
TX) to estimate the energy and protein intake (g/kg/day) for each participant.

Principal Investigator

Participants will receive 30g of SUSTINEX Hydrolyzed Whey Protein supplement. The
participants will be asked to add it to their soft food or their beverages to reach the
goal of consuming 30g daily for 12 weeks (3months).

Receive no intervention- usual care, will receive the standard care of the clinic without
supplemented with PS.

Effectiveness of Protein Supplementation on Frailty Improvement, Muscle Strength and Physical Performance Among Pre-Frail Elderly People

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?