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

NCT05648617 | Unknown Early Phase 1

• 1 other identifier: UPM UNIVERSITY
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Frailty; Muscle Weakness; Physical Dependence; Weight Loss

Keywords

Frailty; Protein Supplements; Elderlies; Muscle Strength; Physical Performance

Outcome Measures

Primary Outcomes (9)

• To study the differences in frailty status, scores and its phenotypes for protein supplemented group (PSG) and control group (CG) from pre- and post-intervention (3 months after intervention starts) in the prefrail elderlies.

  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.

  Baseline & after 12 weeks of the intervention.

• To compare the changes in body weight, lean body mass, muscle mass, total body fat for protein supplemented group (PSG) and control group (CG) from pre- and post-intervention (3 months after intervention starts) in the prefrail elderlies.

  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).

  Baseline, 6th, and 12th week of the intervention.

• To compare pre- and post-intervention changes in Body Mass Index BMI, for the interventional group (PSG) and control group (CG) in the prefrail elderly.

  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.

  Baseline, 6th, and 12th week of the intervention.

• To assess pre- and post-intervention score changes in the balance test, one of the short physical performance battery (SPPB) tests, for the interventional group (PSG) and control group (CG) in the prefrail elderly.

  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.

  Baseline, 6th, and 12th week of the intervention.

• To compare pre- and post-intervention score changes in the gait speed test, one of the short physical performance battery (SPPB) tests, for the interventional group (PSG) and control group (CG) in the prefrail elderly.

  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.

  Baseline, 6th, and 12th week of the intervention.

• To compare pre- and post-intervention score changes in the sit-to-stand test, the third component of the short physical performance battery (SPPB) tests, for the interventional group (PSG) and control group (CG) in the prefrail elderly.

  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.

  Baseline, 6th, and 12th week of the intervention.

• To assess pre- and post-intervention physical performance level changes using short physical performance battery (SPPB) tests, for the interventional group (PSG) and control group (CG) in the prefrail elderly.

  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.

  Baseline, 6th, and 12th week of the intervention.

• To assess the changes in the muscle strength for interventional group (PSG) and control group (CG) from pre- and post-intervention (3 months after intervention starts) in the prefrail elderlies.

  Handgrip strength will be measured by Hand dynamometer

  Baseline, 6th, and 12th week of the intervention.

• To assess the changes in dietary intake (Energy, protein) for interventional group (PSG) and control group (CG) from pre-intervention and post-intervention.

  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.

  Baseline, and 12th week of the intervention.

Study Arms (2)

Protein Supplement group

ACTIVE COMPARATOR

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).

Dietary Supplement: SUSTINEX Hydrolyzed Whey Protein

control group

NO INTERVENTION

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

Interventions

SUSTINEX Hydrolyzed Whey Protein DIETARY_SUPPLEMENT

Participants will receive 30g of SUSTINEX Hydrolyzed Whey Protein. The participants will be asked to add it to = to reach the goal of consuming 30g daily. SUSTINEX Whey Protein Plus is an authorized protein supplement which is manufactured and made in Malaysia by Nova Laboratories Sdn. Bhd. (179832-D). It consists of whey protein isolate and whey protein hydrolyze to achieve sufficient protein requirement.

Protein Supplement group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-frail men or women aged 60 years and above (Fried criteria: score ≥1 but \<3 out of 5).
• Willing to give informed consent to be randomized to either the protein supplement or control group
• Willing to follow the study protocol.

You may not qualify if:

• Non or Frail elderlies (Fried criteria)
• Diagnosed with chronic diseases include: (heart-related disease, COPD, stroke, cancer, asthma, renal dysfunction, terminally ill), bedridden.
• Already involved or still participating in any health interventional studies.
• Participants who consume protein supplements
• Any sustained fracture (hip, vertebrata) in past six month, any surgery (hip, abdominal area) in past six month

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

MeSH Terms

Conditions

Frailty; Muscle Weakness; Weight Loss

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Body Weight Changes; Body Weight

Study Officials

• Associate Professor Dr Siti Nur 'Asyura B Adznam, Ass.prof

  University Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ala'a H Al-Rawhani, Master

CONTACT

+60145168469; alaa.alrawhani95@gmail.com

Associate Professor Dr Siti Nur 'Asyura B Adznam, Ass.prof

CONTACT

+603-89472481; asyura@upm.edu.my

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: December 13, 2022
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share