Summary
High-protein diet (>=1.2 g/kg/day) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Sarcopenia. ClinicalTrials.gov lists 5 registered trials linking High-protein diet (>=1.2 g/kg/day) to Sarcopenia: 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 85 participants. Registration activity spans 2014 to 2023. No published literature item is linked to High-protein diet (>=1.2 g/kg/day) and Sarcopenia in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Sarcopenia ranks 82 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 13.0 (trials 8.0, literature 0.0, tier 5, approved bonus 0.0) |
| Registered trials | 5 total: 0 recruiting, 0 active / not yet recruiting, 2 completed, 3 other |
| Linked publications | 0 |
| Agent type | Behavioural (Lifestyle) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Reversing decline in aging muscles: expected trends, impacts and remedies · Halma M, Marik P, Varon J, Tuszynski J · 2025 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03860194 | Effects of Dietary Supplements on Sarcopenic Elders 2017 | completed | Not applicable | 85 |
| NCT02371278 | Leucine Co-ingestion and Myofibrillar Protein Synthesis in Older Adults 2015 | completed | Not applicable | 20 |
| NCT02379026 | Lifestyle Modifications for the Treatment of Sarcopenic Obesity 2014 | status unknown | Not applicable | 18 |
| NCT05912309 | Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality and Function in Postmenopausal Women With Overweight and Obesity 2023 | status unknown | Not applicable | 78 |
| NCT03024125 | High vs Normal Protein Diets, Resistance Exercise, Lean Mass and Strength Gains 2016 | status unknown | Not applicable | 20 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: Reversing decline in aging muscles: expected trends, impacts and remedies · Halma M, Marik P, Varon J, Tuszynski J · 2025.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is High-protein diet (>=1.2 g/kg/day) approved for Sarcopenia?
High-protein diet (>=1.2 g/kg/day) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Sarcopenia. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is High-protein diet (>=1.2 g/kg/day) in clinical trials for Sarcopenia?
ClinicalTrials.gov lists 5 registered trials linking High-protein diet (>=1.2 g/kg/day) to Sarcopenia: 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 85 participants. Registration activity spans 2014 to 2023.
What does the evidence show for High-protein diet (>=1.2 g/kg/day) in Sarcopenia?
High-protein diet (>=1.2 g/kg/day) has 2 completed registered trials for Sarcopenia but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.