Effectiveness of Protein Supplementation on Frailty Improvement, Muscle Strength and Physical Performance Among Pre-Frail Elderly People in Selangor- Malaysia: A Randomized Clinical Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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.
时间窗: Baseline, 6th, and 12th week of the intervention.
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.
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.
时间窗: Baseline, 6th, and 12th week of the intervention.
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).
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.
时间窗: Baseline, 6th, and 12th week of the intervention.
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.
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.
时间窗: Baseline, 6th, and 12th week of the intervention.
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.
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.
时间窗: Baseline, 6th, and 12th week of the intervention.
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.
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.
时间窗: Baseline & after 12 weeks of the intervention.
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.
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.
时间窗: Baseline, 6th, and 12th week of the intervention.
Handgrip strength will be measured by Hand dynamometer
To assess the changes in dietary intake (Energy, protein) for interventional group (PSG) and control group (CG) from pre-intervention and post-intervention.
时间窗: Baseline, and 12th week of the 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.
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.
时间窗: Baseline, 6th, and 12th week of the intervention.
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.
次要结局
未报告次要终点
研究者
Alaa Hussein Alrawhani
Principal Investigator
Universiti Putra Malaysia