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N-3 Polyunsaturated Fatty Acid Supplementation for Muscle Health in Community-Dwelling Older Adults at High Risk of Sarcopenia: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial

N-3 Polyunsaturated Fatty Acid Supplementation for Muscle Health in Community-Dwelling Older Adults at High Risk of Sarcopenia: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110506
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Interventions

High eicosapentaenoic acid (EPA) group:High-EPA formulation (EPA >= 85%), total daily dose 2.5g, taken orally in two divided doses with meals
High docosahexaenoic acid (DHA) group:High-DHA formulation (DHA >= 85%), total daily dose 2.5g, taken orally in two divided doses with meals
High SN2-DHA group:High SN2-DHA formulation , total daily dose 2.5g, taken orally in two divided doses with meals
Corn oil control group:Corn oil formulation , total daily dose 2.5g, taken orally in two divided doses with meals

Sponsors

Ruijin Hospital, Shanghai Jiaotong Univerdity School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Sign a dated written consent form and agree to participate in the study; 2. Commit to following the study protocol and completing all scheduled follow-ups and assessments; 3. Be at least 60 years old, of any gender, retired or primarily living in the community; 4. Have stable body weight over the past six months (unintentional weight loss not exceeding 5%) and be in good enough health to receive nutritional intervention; 5. Meet at least one sarcopenia risk criterion defined by the Asian Working Group for Sarcopenia (AWGS 2019): grip strength below 28 kg for men or below 18 kg for women; 6. Be able to walk independently, have no severe disability, and be able to complete physical assessments and functional tests; 7. Have no serious cognitive impairment and be able to understand the study process and cooperate with questionnaire assessments; 8. Be willing and able to take the fish oil supplement provided by the study daily.

Exclusion criteria

Exclusion criteria: 1. Confirmed diagnosis of severe sarcopenia or neuromuscular diseases affecting skeletal muscle function (such as myasthenia gravis, progressive muscular dystrophy); 2. Severe dysfunction of major organs such as heart, brain, liver, or kidney, or cancer (such as heart failure, recent myocardial infarction, sequelae of stroke, active liver disease, advanced renal disease, or severe cancer); 3. Significant mobility impairment (e.g., severe arthritis, Parkinson's disease, or stroke that prevents walking or completing strength and function assessments); 4. Known allergic reactions to fish, seafood, or research oils; 5. Suffering from diseases that affect fat absorption (such as severe pancreatitis, biliary obstruction, or short bowel syndrome); 6. Current use or recent (within six months) use of drugs that affect muscle metabolism (such as systemic glucocorticoids, anabolic steroids) or high-dose fish oil/other nutritional supplements; 7. Moderate to severe cognitive impairment or mental illness, resulting in inability to understand the study process or cooperate with the assessment; 8. Participating in other clinical trials or receiving investigational treatment in the past three months; 9. The investigator determines that the patient is not suitable for participation in the study based on health status, compliance or safety issues.

Design outcomes

Primary

MeasureTime frame
Handgrip Strength;

Secondary

MeasureTime frame
Skeletal Muscle Mass;Physical Function;Inflammation and Metabolism-Related Blood Biomarkers;Gut Microbiota Diversity;

Countries

China

Contacts

Public ContactDongsheng Bian

Ruijin Hospital, Shanghai Jiaotong Univerdity School of Medicine

biandd1211@163.com+86 150 0036 8329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026