Weight Loss Clinical Trial
Official title:
Effectiveness of Protein Supplementation on Frailty Improvement, Muscle Strength and Physical Performance Among Pre-Frail Elderly People in Selangor- Malaysia: A Randomized Clinical Study
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | October 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universiti Putra Malaysia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
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