Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04516421
Status:
UNKNOWN
Last Update Posted:
2022-02-14
First Post:
2020-08-10
Brief Title:
Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia
Sponsor:
Asia University
Organization:
Asia University
Study Overview
Official Title:
Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia A Randomized Double-blind Placebo-controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Declines in muscle mass and strength are expected with aging but physical inactivity and low protein intake have been suggested as risk factors of sarcopenia So far lifestyle interventions especially exercise and nutritional supplementation prevail as mainstays of treatment for sarcopenia
Objective To explore the effect and benefits of protein supplementation on the improvement of muscle mass and physical performance in older people with sarcopenia
Design A randomized double-blind placebo-controlled clinical trial Methods Participants aged 65-95y who meet the following criteria will be invited 1 muscle mass bioimpedance 70 kgm² male and 57 kgm² female 2 handgrip strength 28 kg male and 18 kg female and 3 low physical performance 6-m gait Speed 10 ms Study participants will be randomly assigned to two groups The experimental group will receive a 12-week intervention withprotein 14g BCAA44g drink per day while the parallel control group will receive a placebo oat drink per day
Participants in the control group will be asked to maintain participants usual diet and physical activity There are 3 time-points to measure outcomes and observe other required information at week 0baseline 6 and 12
Objective To explore the effect and benefits of protein supplementation on the improvement of muscle mass and physical performance in older people with sarcopenia
Design A randomized double-blind placebo-controlled clinical trial Methods Participants aged 65-95y who meet the following criteria will be invited 1 muscle mass bioimpedance 70 kgm² male and 57 kgm² female 2 handgrip strength 28 kg male and 18 kg female and 3 low physical performance 6-m gait Speed 10 ms Study participants will be randomly assigned to two groups The experimental group will receive a 12-week intervention withprotein 14g BCAA44g drink per day while the parallel control group will receive a placebo oat drink per day
Participants in the control group will be asked to maintain participants usual diet and physical activity There are 3 time-points to measure outcomes and observe other required information at week 0baseline 6 and 12
Detailed Description:
Background Sarcopenia is defined as an abnormal loss of muscle mass and strength Declines in muscle mass and strength are expected with aging but physical inactivity and low protein intake have been suggested as risk factors of sarcopenia Recently Taiwan is known as the fastest-aging nation in the world and the prevalence of sarcopenia has been reported as 39-73 even more 9-64 in Dr Chens study So far lifestyle interventions especially exercise and nutritional supplementation prevail as mainstays of treatment for sarcopenia
Objective To explore the effect and benefits of protein supplementation on the improvement of muscle mass and physical performance in older people with sarcopenia
Study design A randomized double-blind placebo-controlled clinical trial which will be conducted between September and November 2020
Participants The study will be conducted in Keelung Taiwan A total of 9 day-care centers including 180 over 65 years of residents will be invited to participate the study via telephone calls
Eligible participants will be invited to attend this randomized double-blind placebo-controlled 2-parallel-groups trial and will be randomly assigned to the experimental and control groups with 11 ratio
Intervention The intervention period will be 12 weeks The control group will receive 150cc placebo oat drink 15g protein 05g fat 01g carbohydrate each pack Zhan Xuan Co Ltd Taiwan per day five days per week while the experimental group will receive 150cc protein supplementation drink 14g protein 06g fat 7g carbohydrate 44 g BCAA 24g glutamate 05g arginine and 04g taurine each pack Affix Health Taiwan Branch per day five days per week
Supplementation in the experimental group contains 90 kcald and the placebo oat drink contains 83kcald Participants in the control group will be asked to maintain participants usual diet and physical activity There are 3 time-points to measure outcomes and observe other required information at week 0baseline 6 and 12
Sample size calculation Referring to the setting in a published paper that gave a sample size of 30 participantsgroup a sample size of 40 participants in each group is considered in the study by considering potential dropouts
Random assignment and blinding An independent external researcher prepared a computer generated cluster random sampling After random assignment the external researcher newly assigned a subject ID to each participant All other study personnel and participants remained blinded to the identity codes throughout the course of the study When participants withdrew from or completed the study researchers were provided with the participants identities and the participants were told what supplement participants had received
Ethical approval The study was approved by Taipei Hospital Human Trial Committee of the Ministry of Health and Welfare All participants were assured that data collected from participants would be strictly confidential and the physical condition and safety were given priority Investigators conducted intervention only after obtaining participants ethical approval registration number TH-IRB-00190046 Anyone who feel uncomfortable during the study will be allowed to quit immediately with no any restriction
Study measurement Kihon Checklist MNA GDS-SF SPPB IADL MMSE handgrip 6m gait speed SMI SF-12 questionnaire and Tw-FROP-Com
Statistical methods Statistical analysis was conducted using the IBM SPSS software version 22 IBM Corporation New York NY An intention-to-treat analysis was performed 1 Descriptive statistics describe the distribution of category variables by number and percentage and the mean and standard deviations describe the distribution of continuous variables 2 Inference statistics chi-square to verify whether the pre-measured category variants between the experimental group and the control group are homogeneous ANOVA Check whether the continuous variables measured between the experimental group and the control group are homogeneous Generalized estimating equations GEE with interactions of time and group in the models will be conducted to evaluate the intervention effect A two-sided p-value 005 is considered statistically significant
Objective To explore the effect and benefits of protein supplementation on the improvement of muscle mass and physical performance in older people with sarcopenia
Study design A randomized double-blind placebo-controlled clinical trial which will be conducted between September and November 2020
Participants The study will be conducted in Keelung Taiwan A total of 9 day-care centers including 180 over 65 years of residents will be invited to participate the study via telephone calls
Eligible participants will be invited to attend this randomized double-blind placebo-controlled 2-parallel-groups trial and will be randomly assigned to the experimental and control groups with 11 ratio
Intervention The intervention period will be 12 weeks The control group will receive 150cc placebo oat drink 15g protein 05g fat 01g carbohydrate each pack Zhan Xuan Co Ltd Taiwan per day five days per week while the experimental group will receive 150cc protein supplementation drink 14g protein 06g fat 7g carbohydrate 44 g BCAA 24g glutamate 05g arginine and 04g taurine each pack Affix Health Taiwan Branch per day five days per week
Supplementation in the experimental group contains 90 kcald and the placebo oat drink contains 83kcald Participants in the control group will be asked to maintain participants usual diet and physical activity There are 3 time-points to measure outcomes and observe other required information at week 0baseline 6 and 12
Sample size calculation Referring to the setting in a published paper that gave a sample size of 30 participantsgroup a sample size of 40 participants in each group is considered in the study by considering potential dropouts
Random assignment and blinding An independent external researcher prepared a computer generated cluster random sampling After random assignment the external researcher newly assigned a subject ID to each participant All other study personnel and participants remained blinded to the identity codes throughout the course of the study When participants withdrew from or completed the study researchers were provided with the participants identities and the participants were told what supplement participants had received
Ethical approval The study was approved by Taipei Hospital Human Trial Committee of the Ministry of Health and Welfare All participants were assured that data collected from participants would be strictly confidential and the physical condition and safety were given priority Investigators conducted intervention only after obtaining participants ethical approval registration number TH-IRB-00190046 Anyone who feel uncomfortable during the study will be allowed to quit immediately with no any restriction
Study measurement Kihon Checklist MNA GDS-SF SPPB IADL MMSE handgrip 6m gait speed SMI SF-12 questionnaire and Tw-FROP-Com
Statistical methods Statistical analysis was conducted using the IBM SPSS software version 22 IBM Corporation New York NY An intention-to-treat analysis was performed 1 Descriptive statistics describe the distribution of category variables by number and percentage and the mean and standard deviations describe the distribution of continuous variables 2 Inference statistics chi-square to verify whether the pre-measured category variants between the experimental group and the control group are homogeneous ANOVA Check whether the continuous variables measured between the experimental group and the control group are homogeneous Generalized estimating equations GEE with interactions of time and group in the models will be conducted to evaluate the intervention effect A two-sided p-value 005 is considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None