Muscle LossNCT05828134
Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults
A study testing protein-enriched soup in people with Muscle Loss and Muscle Weakness, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss, Muscle Weakness
- What is being tested?
- protein-enriched soup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2021to 4 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Muscle Loss, Muscle Weakness
- Being tested
- protein-enriched soup
- Keywords
- Laurel Corporation, Protein-Enriched Soup
- Medical subject headings
- Muscular Atrophy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein-enriched soupOther
The participants in experimental group have a protein-enriched soup a day and do exercise a week
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | No intervention | The control group only performed routine data collection and gave them dietary suggestion. |
| Protein-enriched soup group | Experimental | Protein-enriched soup /day for use as a supplement with meals and strength training /week Receives: Other: protein-enriched soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 4, 12 weeks
Secondary outcomes (23)
Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline numbers of Complete blood count after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Measured: baseline, 4, 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
Measured: baseline, 4, 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
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Measured: baseline, 4, 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
Measured: baseline, 4, 12 weeks
Change from baseline Nutrition intake after 12 weeks
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Measured: baseline, 4, 12 weeks
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
Measured: baseline, 4, 12 weeks
Change from baseline cognitive ability after 12 weeks
measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
Measured: baseline, 4, 12 weeks
Change from baseline body composition analysis after 12 weeks
measured by RASM
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Measured: baseline, 4, 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Measured: baseline, 4, 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
Measured: baseline, 4, 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
Measured: baseline, 4, 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Measured: baseline, 4, 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.
Measured: baseline, 4, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start11 Mar 2021
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Laurel Enterprises Corporation
- Responsible party
- Sponsor
- Investigators
- Liang-Kung Chen, MD.PhD., Principal investigator, Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828134
- Sponsor's protocol ID
- YM109172F
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05828134
- Acronym / sponsor ID
- YM109172F
- Conditions
- Muscle Loss, Muscle Weakness
- Keywords
- Laurel Corporation, Protein-Enriched Soup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Laurel Enterprises Corporation
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –The control group only performed routine data collection and gave them dietary suggestion. |
| Protein-enriched soup group | Experimental | Other: protein-enriched soupProtein-enriched soup /day for use as a supplement with meals and strength training /week |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein-enriched soupThe participants in experimental group have a protein-enriched soup a day and do exercise a week | Other | Protein-enriched soup group |
Primary outcome
Changes from baseline physical function after 12 weeks
Time frame: baseline, 4, 12 weeks
measured by hand grip, 6-minute walk distance, six-meter walking speed, 5 times sit-to-stand
23 secondary outcomes
Change from baseline numbers of Complete blood count after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Time frame: baseline, 4, 12 weeks
Changes form baseline QUALITY OF LIFE after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline Nutrition intake after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline depression after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline cognitive ability after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline body composition analysis after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Time frame: baseline, 4, 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Time frame: baseline, 4, 12 weeks
Change in International Physical Activity Questionnaire (IPAQ) after 12 weeks
Time frame: baseline, 4, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-Kung Chen, MD.PhD. principal investigator
Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein-enriched soup in people with Muscle Loss and Muscle Weakness, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline physical function after 12 weeks (time frame: baseline, 4, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.