Back to resultsEnhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults
Primary Purpose
Muscle Loss, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
protein-enriched soup
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Loss focused on measuring Laurel Corporation, Protein-Enriched Soup
Eligibility Criteria
Inclusion Criteria: People who aged 50-75 years Patients with following characteristics: feeling loss in activity detecting decline in self's walking speed. feeling tired of doing everything. having fell in last year. People willing to follow the program and cooperate with us for following tracking. People who are neither vegan nor vegetarian People agree and be able to sign the informed consent. the protein of the daily meal are less than 1.0g/kg Exclusion Criteria: People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets. People with any disease affecting their limbs, including: having fracture on limbs in the past 6 months having severe arthritis in the past 6 months any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke). People with intermittent limp caused by peripheral artery diseases People with weak control of mental disorder People with weak control of Cardiopulmonary disease People with weak control of Malignant tumor People with weak control of kidney diseases (eGFR <60ml/min/1.73) People with Visual impairment and Hearing disorder which cannot help to complete the program. People who have underwent hormone treatment and planned to undergo hormone treatment during program session. Any other condition that PI recognized as not suitable
Sites / Locations
- National Yang Ming Chiao Tung University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care group
Protein-enriched soup group
Arm Description
The control group only performed routine data collection and gave them dietary suggestion.
Protein-enriched soup /day for use as a supplement with meals and strength training /week
Outcomes
Primary Outcome Measures
Changes from baseline physical function after 12 weeks
measured by hand grip, 6-minute walk distance, six-meter walking speed, 5 times sit-to-stand
Secondary Outcome Measures
Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Changes form baseline QUALITY OF LIFE after 12 weeks
measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition
Change from baseline Nutrition intake after 12 weeks
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Change from baseline depression after 12 weeks
measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition
Change from baseline cognitive ability after 12 weeks
measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
Change from baseline body composition analysis after 12 weeks
measured by RASM
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change in International Physical Activity Questionnaire (IPAQ) after 12 weeks
Change in physical activity measured by IPAQ, indicates that spent being physically active thin the prior 7 days.There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations from baseline to 12 weeks in all participants.
Full Information
NCT ID
NCT05828134
First Posted
April 13, 2023
Last Updated
June 13, 2023
Sponsor
National Yang Ming University
Collaborators
Laurel Enterprises Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05828134
Brief Title
Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults
Official Title
Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults: A Randomized Controlled Trial Investigating the Benefits of Protein-enriched Supplementation and Weekly Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Laurel Enterprises Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the effects of protein-enriched soup plus exercise on muscle mass and muscle strength.
Besides, the investigators use the valued-based healthcare standard set as well as the Center for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive Assessment , and Mini Nutritional Assessment as outcome measures and to use the trial in validate additional supplement protein-enriched soup plus exercise could improve the vitality and health of mid-aged and old adults.
Detailed Description
With aging, functions of every organs become to decline. Muscle mass, is one of the decline. According to previous research, adults would lose 40% among from aged 20 to 70. If muscle mass decline combining with the decline of muscle strength is so called Sarcopenia.When muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In addition, activity and life quality are also responsible for falling, cognitive difficulty, disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia through this program and develop prevention strategy and model to mollify the the negative effect of rapid aging society.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Loss, Muscle Weakness
Keywords
Laurel Corporation, Protein-Enriched Soup
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
The control group only performed routine data collection and gave them dietary suggestion.
Arm Title
Protein-enriched soup group
Arm Type
Experimental
Arm Description
Protein-enriched soup /day for use as a supplement with meals and strength training /week
Intervention Type
Other
Intervention Name(s)
protein-enriched soup
Intervention Description
The participants in experimental group have a protein-enriched soup a day and do exercise a week
Primary Outcome Measure Information:
Title
Changes from baseline physical function after 12 weeks
Description
measured by hand grip, 6-minute walk distance, six-meter walking speed, 5 times sit-to-stand
Time Frame
baseline, 4, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline numbers of Complete blood count after 12 weeks
Description
Change from baseline numbers of Complete blood count after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Albumin after 12 weeks
Description
Change from baseline concentration of Albumin after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Description
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Description
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of blood urea nitrogen after 12 weeks
Description
Change from baseline concentration of blood urea nitrogen after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Creatinin after 12 weeks
Description
Change from baseline concentration of Creatinin after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Fasting glucose after 12 weeks
Description
Change from baseline concentration of Fasting glucose after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Fasting insulin after 12 weeks
Description
Change from baseline concentration of Fasting insulin after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Description
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Description
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Leptin after 12 weeks
Description
Change from baseline concentration of Leptin after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of urine protein after 12 weeks
Description
Change from baseline concentration of urine protein after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Changes form baseline QUALITY OF LIFE after 12 weeks
Description
measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline Nutrition intake after 12 weeks
Description
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline depression after 12 weeks
Description
measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline cognitive ability after 12 weeks
Description
measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline body composition analysis after 12 weeks
Description
measured by RASM
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Total Cholesterol after 12 weeks
Description
Change from baseline concentration of Total Cholesterol after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of Triglyceride after 12 weeks
Description
Change from baseline concentration of Triglyceride after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Description
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Description
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Description
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Time Frame
baseline, 4, 12 weeks
Title
Change in International Physical Activity Questionnaire (IPAQ) after 12 weeks
Description
Change in physical activity measured by IPAQ, indicates that spent being physically active thin the prior 7 days.There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations from baseline to 12 weeks in all participants.
Time Frame
baseline, 4, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
People who aged 50-75 years
Patients with following characteristics:
feeling loss in activity
detecting decline in self's walking speed.
feeling tired of doing everything.
having fell in last year.
People willing to follow the program and cooperate with us for following tracking.
People who are neither vegan nor vegetarian
People agree and be able to sign the informed consent.
the protein of the daily meal are less than 1.0g/kg
Exclusion Criteria:
People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets.
People with any disease affecting their limbs, including:
having fracture on limbs in the past 6 months
having severe arthritis in the past 6 months
any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
People with intermittent limp caused by peripheral artery diseases
People with weak control of mental disorder
People with weak control of Cardiopulmonary disease
People with weak control of Malignant tumor
People with weak control of kidney diseases (eGFR <60ml/min/1.73)
People with Visual impairment and Hearing disorder which cannot help to complete the program.
People who have underwent hormone treatment and planned to undergo hormone treatment during program session.
Any other condition that PI recognized as not suitable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-Kung Chen, MD.PhD.
Organizational Affiliation
Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults
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