An interventional study of Protein Supplement and Protein-free Supplement in Sarcopenia, Frailty and Malnutrition; Protein, sponsored by University of Zurich. Completed at 2 sites in Switzerland. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by University of Zurich · Not applicable, Interventional, and Prevention
Among 18 studies in Sarcopenia with a site in Switzerland — 4 open to participants now, 5 under way, 1 of them phase 3. Sarcopenia · Switzerland.
Among the 18 studies in Sarcopenia with a site in Switzerland, this one has the largest enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 7 with no phase, and was the 5th registered.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's enrollment of 801 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →4 of the 18 studies in Sarcopenia with a site in Switzerland are open now, in 2 countries. Each count lists the studies.
Of the 247 Sarcopenia studies recruiting now, 153 (62%) set no upper age limit and 33 (13%) stop at 75 or younger; 9 take children under 18; 65 take healthy volunteers.
This study: 75 Years and older · all sexes · healthy volunteers too.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2018.
Median enrollment 202 across the 13 interventional studies, 350 across the 5 observational. Of the 13 that completed or were terminated, 2 (15%) have results posted.
3 of 18 have an industry lead sponsor. The 10 most frequent:
University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
University of Zurich has 1 study filed under Sarcopenia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Sarcopenia with a site in Switzerland, from their registry updates:
Nothing recorded among them since 2026-09-25.
Physical inactivity and protein malnutrition have been implicated to be key and modifiable causes of enhanced muscle mass loss among seniors. However, the individual benefit, as well as the additive or possibly interactive benefit of exercise and Protein supplementation on fall prevention has yet to be confirmed in a large clinical trial. This study aims to test the individual and combined effect and cost-effectiveness of a simple home exercise program and / or protein supplementation on the risk of falling in seniors at high risk of progressive muscle mass loss and sarcopenia.
The number of seniors age 75 and older is predicted to double by 2030, as is the number of seniors with mobility disability, physical frailty and resulting consequences, such as falls and loss of autonomy. This causes an enormous challenge to the individual, to medical care, and the society as a whole. A condition that is considered central to the development of physical frailty and its consequences is sarcopenia, the loss of muscle mass and strength. To date sarcopenia is underdiagnosed in clinical care and effective treatments for sarcopenia are missing.
This study aims to test the individual and combined effect and cost-effectiveness of a simple home exercise program and / or protein supplementation on the risk of falling in seniors at high risk of progressive muscle mass loss and sarcopenia.
The STRONG trial will be a 2x2 factorial design multi-centre double-blind randomized controlled clinical trial among 800 senior men and women; study duration is 12 months. The primary endpoint is the rate of falling. Key secondary endpoints include functional decline, and the proportion of seniors with frailty, sarcopenia, and loss of autonomy. STRONG will further assess the cost-effectiveness of the interventions based on health care utilization data collected every 2 months from each participant and observed incidence of the endpoints. Mechanistic endpoints include change in muscle mass by DXA(arms and legs), change in myostatin levels, and muscle quality (based on MRI).
The interventions are (1) a simple home exercise program (a validated strength-enhancing or a control joint flexibility exercise program) to be performed 3x30 minutes/week; and (2) protein supplementation (either 20g of whey protein or isocaloric powder given in two portions for breakfast and dinner each day). All participants will receive a control dose of 24'000 IU vitamin D per month (equivalent to 800 IU vitamin D/day) to ensure that over 97% of STRONG participants will be vitamin D replete (25-hydroxyvitamin D > 20 ng/ml) during the course of the trial.
The trial will have clinical visits at baseline, 6 months, and 12 months. In between clinical visits, telephone interviews will be performed every 2 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will ingest twice daily 23.7 g of L-leucine-enriched whey protein isolate powder (equivalent to 20 g of Protein) and perform a simple home exercise strength program (3x30 minutes/week)
Dietary Supplement: Protein Supplement · Procedure: Active Exercise
Participants will ingest twice daily 23.7 g of a protein-free, isocaloric powder blend and perform a simple home exercise strength program (3x30 minutes/week)
Dietary Supplement: Protein-free Supplement · Procedure: Active Exercise
Participants will ingest twice daily 23.7 g of L-leucine-enriched whey protein isolate powder (equivalent to 20 g of Protein) and perform a joint flexibility home exercise program (3x30 minutes/week)
Dietary Supplement: Protein Supplement · Procedure: Control Exercise
Participants will ingest twice daily 23.7 g of a protein-free, isocaloric powder blend and perform a joint flexibility home exercise program (3x30 minutes/week)
Dietary Supplement: Protein-free Supplement · Procedure: Control Exercise
Predosed protein powder; can be added to various dishes and drinks
Also known as: Moltein® Ready-to-Shake
Predosed protein-free powder; can be added to various dishes and drinks
Program includes five strength exercises that can be easily performed at home
Program includes five flexibility exercises that can be easily performed at home
Rate of falling
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
Time frame: 12 months
Functional decline (change in lower extremity function)
will be assessed with the Short Physical Performance Battery (SPPB)
Time frame: Baseline, 6, and 12 months
Proportion of seniors with any falls and injurious falls
using the same method as for the primary endpoint
Time frame: every 2 months over 12 months
Proportion of seniors with established frailty
Frailty will be defined as 3 out of the following 5 criteria are met: 1) weight loss of \> 4.5 kg in the last 12 months; 2) reduced grip strength in Martin Vigorimeter test: ♂ ≤ 64 kPa, ♀ ≤ 42 kPa; 3) standardized question on exhaustion as published by Fried et al.; 4) gait speed \< 1 m/s; 5) 6-minute walk test \< 300 meters
Time frame: Baseline, 6, and 12 months
Proportion of seniors with sarcopenia
will be assessed both with the Baumgartner definition (muscle mass alone) and the European Working Group definition by Cruz-Jentoft24 (composite definition of muscle mass and impaired grip strength or gait speed)
Time frame: Baseline, 6, and 12 months
Proportion of seniors admitted to nursing homes (loss of autonomy)
participants will be asked at visits/phone calls
Time frame: every 2 months over 12 months
Change in gait speed
Gait speed will be measured over a distance of 4 meters. The participants will be asked to walk in their usual pace
Time frame: Baseline, 6, and 12 months
Change in reaction time
Reaction time will be assessed with repeated chair stands (5 repeats as part of the SPPB)
Time frame: Baseline, 6, and 12 months
Change in grip strength
Measured with Martin Vigorimeter
Time frame: Baseline, 6, and 12 months
Change in aerobic capacity
Aerobic capacity will be assessed with the 6 minute walk test. A walked distance of \< 300 m will be used as a frailty criteria
Time frame: Baseline, 6, and 12 months
Change in muscle mass (arms and legs)
will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare)
Time frame: Baseline, 6, and 12 months
Change in bone mineral density (hip and lumbar spine)
will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare)
Time frame: Baseline and 12 months
Change in physical activity
will be assessed by an excerpt from the Nurses' Health Study (NHS) questionnaire
Time frame: Baseline, 6, and 12 months
Change in quality of life
will be assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale
Time frame: Baseline, 6, and 12 months
Health care utilization
assessed with a simple questionnaire to collect health care utilization information prospectively (MD visit, PT visit, hospitalizations in acute care etc)
Time frame: every 2 months over 12 months
Myostatin
Blood Sample Assessment: Myostatin
Time frame: Baseline, 6, and 12 months
IGF-1
Blood Sample Assessment: Insulin-like growth factor-1
Time frame: Baseline, 6, and 12 months
CRP
Blood Sample Assessment: C-Reactive Protein
Time frame: Baseline, 6, and 12 months
Kidney function
Blood Sample Assessment: creatinine
Time frame: Baseline, 6, and 12 months
25-hydroxyvitamin D
Blood Sample Assessment: 25-hydroxyvitamin D
Time frame: Baseline, 6, and 12 months
Fasting insulin levels
Blood Sample Assessment: fasting insulin levels
Time frame: Baseline, 6, and 12 months
Fasting blood glucose
Blood Sample Assessment: fasting blood glucose
Time frame: Baseline, 6, and 12 months
Change muscle quality (sub-sample of 140 participants)
Assessed with whole Body MRI's in a subsample of f140 participants
Time frame: Baseline and 12 months
Any non-vertebral fracture
All fractures will be confirmed by x-ray or medical record.
Time frame: every 2 months over 12 months
Mortality
will be assessed by personal contact
Time frame: every 2 months over 12 months
Rate of SAEs in general
Serious Adverse Events
Time frame: over 12 months
Rate of SAEs related to study intervention
Serious Adverse Events
Time frame: over 12 months
Adherence to intervention (dietary supplement)
nitrogen excretion from 24-h/spot urine
Time frame: Baseline, 6, and 12 months
Adherence to intervention (dietary supplement)
will be assessed by questionnaire and diary
Time frame: over 12 months
Adherence to intervention (exercise)
will be assessed by questionnaire and diary
Time frame: over 12 months
Covariate: Hearing
will be assessed by a hearing test
Time frame: over 12 months
Ran from Jun 2018 to primary completion in Mar 2025, 80 months.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 80 months is above that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Protein Supplement