Muscle LossNCT03784456
Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults
A study testing 25% protein and 15% protein in people with Muscle Loss and Muscle Weakness, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The subjects of this intervention program are mainly based on community-dwelling mid-aged and older adults. The investigator's program will provide meals containing different proportionated protein.As this project is a double blind test, only the investigators will know which subject corresponding to specific group of… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Muscle Loss, Muscle Weakness, Fragility
- What is being tested?
- 25% protein and 15% protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Feb 2019to 31 Dec 2019
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who aged 40-75 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 can accept undergoing MRI
- 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.
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 are unable to undertake MRI
- 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
The subjects of this intervention program are mainly based on community-dwelling mid-aged and older adults. The investigator's program will provide meals containing different proportionated protein.As this project is a double blind test, only the investigators will know which subject corresponding to specific group of diets.
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 Assesment ,and Mini Nutritional Assessment as outcome measures and to use the randomized controlled trial design to validate if increased protein density diet 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, Fragility
- Being tested
- 25% protein, 15% protein
- 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.
25% proteinDietary supplement
Compared to usual group of 15% protein in meals, intervention group will receive 25% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.
15% proteinDietary supplement
Designed as comparator , compared to empirical arm of 25% protein in meals, intervention group will receive 15% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.
| Study group | Role | What they receive |
|---|---|---|
| 25% protein group | Experimental | This experimental arm will be given meals containing 25% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks. Receives: Dietary Supplement: 25% protein |
| 15% protein group | Active comparator | This control arm will be given meals containing 15% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks. Receives: Dietary Supplement: 15% protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline muscle strength after 12 weeks
measured by hand grip
Measured: baseline,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, 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, 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,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, 12 weeks
Change from baseline endurance after 12 weeks
measured by 6-minute walk distance
Measured: baseline, 12 weeks
Change from baseline walking speed after 12 weeks
measured by six-meter walking speed
Measured: baseline, 12 weeks
Change from baseline timed up and go test after 12 weeks
measured by timed up and go test (TUG) and six-meter walking speed
Measured: baseline, 12 weeks
Secondary outcomes (17)
Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline numbers of Complete blood count after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Measured: baseline,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,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,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,12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Measured: baseline,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,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,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,12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Measured: baseline,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, 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Change from baseline concentration of urine routine after 12 weeks
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start13 Feb 2019
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
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
- Model description
- This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Laurel Corporation, Taiwan
- Responsible party
- Sponsor
- Investigators
- Liang-Kung Chen, MD.PhD., Principal investigator, Aging and Health Research Center, National Yang Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784456
- Sponsor's protocol ID
- 19-001-A-2
- Status last verified
- Feb 2020
- First submitted
- 6 Dec 2018
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults
- ClinicalTrials.gov ID
- NCT03784456
- Acronym / sponsor ID
- 19-001-A-2
- Conditions
- Muscle Loss, Muscle Weakness, Fragility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Laurel Corporation, Taiwan
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Dec 2018 (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.
The subjects of this intervention program are mainly based on community-dwelling mid-aged and older adults. The investigator's program will provide meals containing different proportionated protein.As this project is a double blind test, only the investigators will know which subject corresponding to specific group of diets.
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 Assesment ,and Mini Nutritional Assessment as outcome measures and to use the randomized controlled trial design to validate if increased protein density diet 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
- Single blind (participant)
- Number of arms
- 2
- Model description
- This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.
| Arm | Type | Receives |
|---|---|---|
| 25% protein group | Experimental | Dietary Supplement: 25% proteinThis experimental arm will be given meals containing 25% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks. |
| 15% protein group | Active comparator | Dietary Supplement: 15% proteinThis control arm will be given meals containing 15% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- People who aged 40-75 years
- Patients with following characteristics:
- feeling loss in activity
- detecting decline in self's walking speed.
- feeling tired of doing everything.
Key exclusion criteria (14 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 |
|---|---|---|
| 25% proteinCompared to usual group of 15% protein in meals, intervention group will receive 25% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product. | Dietary supplement | 25% protein group |
| 15% proteinDesigned as comparator , compared to empirical arm of 25% protein in meals, intervention group will receive 15% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product. | Dietary supplement | 15% protein group |
Primary outcome
Changes from baseline muscle strength after 12 weeks
Time frame: baseline,12 weeks
measured by hand grip
Changes form baseline QUALITY OF LIFE after 12 weeks
Time frame: baseline, 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
Time frame: baseline, 12 weeks.
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Change from baseline depression after 12 weeks
Time frame: baseline,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
Time frame: baseline, 12 weeks
measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
Change from baseline endurance after 12 weeks
Time frame: baseline, 12 weeks
measured by 6-minute walk distance
Change from baseline walking speed after 12 weeks
Time frame: baseline, 12 weeks
measured by six-meter walking speed
Change from baseline timed up and go test after 12 weeks
Time frame: baseline, 12 weeks
measured by timed up and go test (TUG) and six-meter walking speed
17 secondary outcomes
Change from baseline numbers of Complete blood count after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Albumin after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Time frame: baseline, 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 27 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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
Aging and Health Research Center, National Yang Ming 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 25% protein and 15% protein 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 14 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 27 Feb 2020. 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 muscle strength after 12 weeks (time frame: baseline,12 weeks). The study lists 8 primary outcomes in all. 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 27 Feb 2020.