None listed
Conditions
Interventions
Dietary Supplement : Study Product: Mealworm hydrolysate (MH) capsules vs. visually identical placebo
Dosage & Frequency: MH group received 2,000 mg/day (1,000 mg after breakfast and 1,000 mg after di
placebo group followed the same regimen
Administration Period: Oral dosing once daily for 12 weeks
Exercise Program: Both groups completed a supervised, moderate-intensity walking regimen (30 minutes
placebo capsules contain no active ingredients.
Sponsors
HANMI NATURAL NUTRITION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 50–75 years 2. Body mass index (BMI) = 18.5 kg/m² and < 30.0 kg/m² 3. Handgrip strength below the 50th percentile (men < 38.90 kg; women < 23.30 kg) based on the mean values from the 2017–2019 Korea National Health and Nutrition Examination Survey 4. No planned changes to lifestyle factors that could affect the trial (e.g., participation in other physical activity programs or intake of additional health supplements) during the intervention period 5. Voluntary written informed consent provided after receiving and understanding the detailed study explanation
Exclusion criteria
Exclusion criteria: 1. History of allergy or adverse reaction to the study product (including shrimp, other shellfish, or chitin) 2. Significant lower-limb musculoskeletal abnormality or injury (e.g., spinal stenosis requiring surgery resulting in gait impairment) 3. Any surgery within 6 months prior to the start of the trial 4. Use of medications or health supplements affecting muscle improvement (e.g., protein powders, amino acid supplements, creatine, Schisandra extract) within 2 weeks prior to the screening visit 5. Participation in an active exercise training program within 3 months prior to the screening visit 6. Fragility hip fracture 7. Dementia or Parkinson’s disease severe enough to impair communication or ambulation (mild symptoms permitted) 8. Diagnosis of severe cerebrovascular disease (e.g., stroke, intracerebral hemorrhage), cardiac disease (e.g., angina, myocardial infarction, heart failure, arrhythmia), or pulmonary disease (e.g., COPD) within 3 months prior to screening 9. Uncontrolled diabetes (fasting blood glucose > 126 mg/dL) 10. Liver disease or AST or ALT levels = 3× the upper limit of normal 11. Kidney disease or serum creatinine > 2.0 mg/dL 12. Uncontrolled hypertension (systolic = 160 mmHg or diastolic = 100 mmHg) 13. Malignancy: history of cancer or current cancer treatment within 5 years prior to screening (excluding non-melanoma skin cancers) 14. History of or current severe psychiatric disorder (e.g., schizophrenia, epilepsy, anorexia nervosa, bulimia nervosa, major depression) or history of alcohol or other substance abuse 15. Use of oral or injectable corticosteroids within 4 weeks prior to screening 16. Habitual alcohol consumption = 140 g/week 17. Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use adequate contraception (e.g., oral contraceptives, hormonal implants, intrauterine devices, condoms, spermicides); women with documented infertility are exempt 18. Participation in another clinical trial within 3 months prior to screening 19. Deemed unable to comply with study requirements or unsuitable for participation in the opinion of the principal investigator or designee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure;Red blood cells;Hematocrit;Neutrophil;Lymphocyte;Platelets;Body temperature;Heartrate;White Blood Cells;Hemoglobin;Monocyte;Eosinophil;Basophil;Aspartate Aminotransferase;Alanine Aminotransferase;Alkaline Phosphatase;Gamma-Glutamyl Transferase;Total Bilirubin;Total Protein;Albumin;Triglyceride;Total Cholesterol;high density lipoprotein-Cholesterol;low density lipoprotein-Cholesterol;Blood Urea Nitrogen;Creatinine;Uric Acid;Glucose;Potassium;Calcium | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | — |
Countries
Korea, Republic of
Contacts
Public ContactSoYoung Ahn
Seoul National University
Outcome results
None listed