SarcopeniaNCT05243472
Impact of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Older Adults
A study testing Protein nutritional supplement in people with Sarcopenia and Muscle Loss, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The study is a 12-week randomized controlled trial designed to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Muscle Loss, Malnutrition
- What is being tested?
- Protein nutritional supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 31 Aug 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People aged 65 years or older
- People with nutritional risk: Mini Nutritional Assessment (MNA) is less than or equal to eleven points.
- People with risk of sarcopenia: SARC-F questionnaire greater than or equal to four points or SARC-CalF questionnaire greater than or equal to eleven points.
- People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the following tracking.
Who cannot join
- People that are unable to cooperate with or accept lacto-vegetarian-based/nuts/gluten foods, such as those who are allergic to dietary content, nuts or gluten, etc.
- According to the PI's judgment, people with severe or poorly controlled conditions include acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.
- People with liver cirrhosis
- People with chronic kidney diseases (eGFR <30ml/min/1.73m2)
- People with severe visual or hearing impairment that prevent the completion of assessment and testing
- People with malignant tumors that have just been diagnosed or are undergoing treatment or are still at risk of recurrence
Show all 10Show fewer
- People are known to be infected with human immunodeficiency virus or HIV antibody-positive.
- People have received hormone therapy within three months before the trial or are expected to receive hormone therapy during the trial
- People are currently or expected to join any other physical training courses or nutrition plans during the trial
- Others are based on the judgment of the PI that participating in this trial may adversely affect the safety of the subjects, hinder the progress of the experiment, or interfere with the evaluation of the outcomes of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Community-Dwelling Older Adults:A 12-Week Randomized Controlled Trial
The study is a 12-week randomized controlled trial designed to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults. Participants are randomly assigned to either an intervention group, which is provided one commercial soup (24-30g of protein) per day for 12 weeks, or the control group, which does not receive this supplement. The investigators also assess the frail status, Mini-Mental Status Examination, Geriatric Depression Scale, Mini Nutritional Assessment, WHOQOL-BREF, and blood tests as outcome measures.
Read the detailed description
As age increases, the muscle mass of the individual will gradually decrease, which will affect muscle strength and function. If the condition continues to deteriorate, the individual may develop a syndrome of "sarcopenia" in the elderly. In addition to age, risk factors related to sarcopenia include living alone, excessive drinking, lack of physical activity, malnutrition, and oral and dental problems. Among them, lack of physical activity and malnutrition are considered potential risk factors for preventing or improving sarcopenia. Sufficient protein intake is an important method for frail elderly people to improve malnutrition and further prevent or reverse sarcopenia. There were few studies in the past. Some studies had enrolled older adults with sarcopenia, but the participants did not necessarily have nutritional risks; other studies had enrolled individuals with nutritional risks but without complete evaluation for sarcopenia (especially muscle mass). In addition, the components of nutritional supplements should also be adjusted in response to different dietary preferences. For example, past studies have rarely provided protein-enriched nutritional supplements that can be used by Lacto-vegetarian. Therefore, this study aims to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults with risk of sarcopenia and malnutrition.
- Conditions
- Sarcopenia, Muscle Loss, Malnutrition
- Being tested
- Protein nutritional supplement
- Keywords
- Older adults, Sarcopenia, Malnutrition
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein nutritional supplementDietary supplement
Participants in the intervention group will receive protein-enriched soups (24-30g of protein). Protein may come from either soy, bean or milk products.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in the control group will not receive any intervention during the study period. |
| Protein nutritional supplement group | Experimental | Participants in the intervention group will receive protein-enriched soups (24-30g of protein) per day for 12 weeks. Protein may come from either soy, bean or milk products. Receives: Dietary Supplement: Protein nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline muscle strength measure by hand grip strength after 12 weeks
measured by hand grip strength
Measured: baseline, 12 weeks
Change from baseline walking speed after 12 weeks
measured by six-meter walking speed
Measured: baseline, 12 weeks
Changes from baseline physical performance after 12 weeks
measured by Short Physical Performance Battery
Measured: baseline, 12 weeks
Changes from baseline frailty after 12 weeks
measured by Clinical Frailty Scale
Measured: baseline, 12 weeks
Changes from baseline frail status after 12 weeks
measured by Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight scale
Measured: baseline, 12 weeks
Changes from baseline cognition after 12 weeks
measured by Mini-Mental Status Examination
Measured: baseline, 12 weeks
Changes from baseline depression after 12 weeks
measured by Geriatric Depression Scale
Measured: baseline, 12 weeks
Changes from baseline quality of life after 12 weeks
measured by WHOQOL-BREF (Taiwan Version)
Measured: baseline, 12 weeks
Changes from baseline physical activity after 12 weeks
measured by the International Physical Activity Questionnaire (IPAQ)
Measured: baseline, 12 weeks
Changes from baseline nutritional status after 12 weeks
measured by Mini-Nutritional Assessment-Short Form (MNA-SF)
Measured: baseline, 12 weeks
Changes from baseline dietary assessment after 12 weeks
measured by Food Frequency Questionnaires (FFQ)
Measured: baseline, 12 weeks
Secondary outcomes (28)
Change from baseline complete blood count 12 weeks
Change from baseline complete blood count 12 weeks
Measured: baseline, 12 weeks
Change from baseline differential count 12 weeks
Change from baseline differential count 12 weeks
Measured: baseline, 12 weeks
Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks
Change from baseline percentage of glycated hemoglobin (HbA1c) 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 (BUN) after 12 weeks
Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of Creatinine after 12 weeks
Change from baseline concentration of Creatinine after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of sodium after 12 weeks
Change from baseline concentration of sodium after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of potassium after 12 weeks
Change from baseline concentration of potassium after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of uric acid after 12 weeks
Change from baseline concentration of uric acid after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of total protein after 12 weeks
Change from baseline concentration of total protein 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 globulin after 12 weeks
Change from baseline concentration of globulin after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of cholesterol after 12 weeks
Change from baseline concentration of cholesterol after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) 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 fasting glucose after 12 weeks
Change from baseline concentration of fasting glucose after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) 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 Vitamin D after 12 weeks
Change from baseline concentration of Vitamin D after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of Vitamin B12 after 12 weeks
Change from baseline concentration of Vitamin B12 after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of homocysteine after 12 weeks
Change from baseline concentration of homocysteine after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of cystatin C after 12 weeks
Change from baseline concentration of cystatin C after 12 weeks
Measured: baseline, 12 weeks
Change from baseline concentration of DHEA-S after 12 weeks
Change from baseline concentration of DHEA-S after 12 weeks
Measured: baseline, 12 weeks
Change from baseline body weight after 12 weeks
Change from baseline body weight after 12 weeks
Measured: baseline, 12 weeks
Change from baseline fat mass after 12 weeks
Change from baseline fat mass after 12 weeks
Measured: baseline, 12 weeks
Change from baseline muscle mass after 12 weeks
Change from baseline muscle mass 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 posted17 Feb 2022
- Study start1 Mar 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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 parallel randomized intervention. The primary purpose of this program is Prevention.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laurel Corporation, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ching-Hui Loh, MD.PhD., Principal investigator, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243472
- Sponsor's protocol ID
- IRB110-246-A
- Status last verified
- Aug 2024
- First submitted
- 6 Jan 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kao SL, Wang JH, Lai HY, Hsiao FY, Chen LK, Loh CH. Daily Supplementation with Protein-Enriched Lacto-Vegetarian Soups and Muscle Health in Community-Dwelling Older Adults: A Randomized Controlled Trial. J Nutr Health Aging. 2025 Mar;29(3):100477. doi: 10.1016/j.jnha.2024.100477. Epub 2025 Jan 16.
PubMed 39823681
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Community-Dwelling Older Adults:A 12-Week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05243472
- Acronym / sponsor ID
- IRB110-246-A
- Conditions
- Sarcopenia, Muscle Loss, Malnutrition
- Keywords
- Older adults, Sarcopenia, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Laurel Corporation, Taiwan
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 17 Feb 2022 (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 study is a 12-week randomized controlled trial designed to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults. Participants are randomly assigned to either an intervention group, which is provided one commercial soup (24-30g of protein) per day for 12 weeks, or the control group, which does not receive this supplement. The investigators also assess the frail status, Mini-Mental Status Examination, Geriatric Depression Scale, Mini Nutritional Assessment, WHOQOL-BREF, and blood tests as outcome measures.
Detailed description
As age increases, the muscle mass of the individual will gradually decrease, which will affect muscle strength and function. If the condition continues to deteriorate, the individual may develop a syndrome of "sarcopenia" in the elderly. In addition to age, risk factors related to sarcopenia include living alone, excessive drinking, lack of physical activity, malnutrition, and oral and dental problems. Among them, lack of physical activity and malnutrition are considered potential risk factors for preventing or improving sarcopenia. Sufficient protein intake is an important method for frail elderly people to improve malnutrition and further prevent or reverse sarcopenia. There were few studies in the past. Some studies had enrolled older adults with sarcopenia, but the participants did not necessarily have nutritional risks; other studies had enrolled individuals with nutritional risks but without complete evaluation for sarcopenia (especially muscle mass). In addition, the components of nutritional supplements should also be adjusted in response to different dietary preferences. For example, past studies have rarely provided protein-enriched nutritional supplements that can be used by Lacto-vegetarian. Therefore, this study aims to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults with risk of sarcopenia and malnutrition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This program is designed as a parallel randomized intervention. The primary purpose of this program is Prevention.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in the control group will not receive any intervention during the study period. |
| Protein nutritional supplement group | Experimental | Dietary Supplement: Protein nutritional supplementParticipants in the intervention group will receive protein-enriched soups (24-30g of protein) per day for 12 weeks. Protein may come from either soy, bean or milk products. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People aged 65 years or older
- People with nutritional risk: Mini Nutritional Assessment (MNA) is less than or equal to eleven points.
- People with risk of sarcopenia: SARC-F questionnaire greater than or equal to four points or SARC-CalF questionnaire greater than or equal to eleven points.
- People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the following tracking.
Key exclusion criteria (10 listed)
- People that are unable to cooperate with or accept lacto-vegetarian-based/nuts/gluten foods, such as those who are allergic to dietary content, nuts or gluten, etc.
- According to the PI's judgment, people with severe or poorly controlled conditions include acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.
- People with liver cirrhosis
- People with chronic kidney diseases (eGFR <30ml/min/1.73m2)
- People with severe visual or hearing impairment that prevent the completion of assessment and testing
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 nutritional supplementParticipants in the intervention group will receive protein-enriched soups (24-30g of protein). Protein may come from either soy, bean or milk products. | Dietary supplement | Protein nutritional supplement group |
Primary outcome
Changes from baseline muscle strength measure by hand grip strength after 12 weeks
Time frame: baseline, 12 weeks
measured by hand grip strength
Change from baseline walking speed after 12 weeks
Time frame: baseline, 12 weeks
measured by six-meter walking speed
Changes from baseline physical performance after 12 weeks
Time frame: baseline, 12 weeks
measured by Short Physical Performance Battery
Changes from baseline frailty after 12 weeks
Time frame: baseline, 12 weeks
measured by Clinical Frailty Scale
Changes from baseline frail status after 12 weeks
Time frame: baseline, 12 weeks
measured by Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight scale
Changes from baseline cognition after 12 weeks
Time frame: baseline, 12 weeks
measured by Mini-Mental Status Examination
Changes from baseline depression after 12 weeks
Time frame: baseline, 12 weeks
measured by Geriatric Depression Scale
Changes from baseline quality of life after 12 weeks
Time frame: baseline, 12 weeks
measured by WHOQOL-BREF (Taiwan Version)
Changes from baseline physical activity after 12 weeks
Time frame: baseline, 12 weeks
measured by the International Physical Activity Questionnaire (IPAQ)
Changes from baseline nutritional status after 12 weeks
Time frame: baseline, 12 weeks
measured by Mini-Nutritional Assessment-Short Form (MNA-SF)
Changes from baseline dietary assessment after 12 weeks
Time frame: baseline, 12 weeks
measured by Food Frequency Questionnaires (FFQ)
28 secondary outcomes
Change from baseline complete blood count 12 weeks
Time frame: baseline, 12 weeks
Change from baseline differential count 12 weeks
Time frame: baseline, 12 weeks
Change from baseline percentage of glycated hemoglobin (HbA1c) 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 (BUN) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of Creatinine after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of sodium after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of potassium after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of uric acid after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of total protein 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 globulin after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of cholesterol after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) 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 fasting glucose after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) 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 Vitamin D after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of Vitamin B12 after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of homocysteine after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of cystatin C after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of DHEA-S after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline body weight after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline fat mass after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline muscle mass 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 7 Aug 2024.
- Derived from this study: PubMed 39823681Kao SL, Wang JH, Lai HY, Hsiao FY, Chen LK, Loh CH. Daily Supplementation with Protein-Enriched Lacto-Vegetarian Soups and Muscle Health in Community-Dwelling Older Adults: A Randomized Controlled Trial. J Nutr Health Aging. 2025 Mar;29(3):100477. doi: 10.1016/j.jnha.2024.100477. Epub 2025 Jan 16.
- Individual participant dataSharing planned: No
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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.
Ching-Hui Loh, MD.PhD. principal investigator
Buddhist Tzu Chi General Hospital
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 nutritional supplement in people with Sarcopenia and Muscle Loss, run by Buddhist Tzu Chi General Hospital 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 4 inclusion and 10 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 7 Aug 2024. 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 measure by hand grip strength after 12 weeks (time frame: baseline, 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243472, which also lists 1 linked publication.
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 7 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.