Sarcopenia
Conditions
Interventions
Administrate 1 packet per day of ALA-containing food (each packet contains 100 mg of ALA/SFC 29 mg/50 mg of zinc yeast) or placebo (each packet contains 0 mg of ALA/SFC 0 mg/ 0 mg of zinc yeast) for 2
Sponsors
Sugimoto Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria is obtained. 1) Patients who meet 1 and 3 or 2 and 3 of the following 1. Gait speed less than 1.0 m/sec or SPPB score less than 9 points or 5 times sit to stand test more than 12 seconds 2. Grip strength less than 28 kg for men and 18 kg for women on either side 3. Skeletal muscle index (BIA method) less than 7.0 kg/m2 for men and 5.7 kg/m2 for women when height-adjusted or less than 0.83 for men and 0.57 for women when BMI-adjusted 2) Age 65 years or older 3) Patients who have given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Patients who meet any of the following categories are excluded from this study 1) Patients undergoing treatment with oral or injected steroids 2) Patients diagnosed with dementia 3) Patients with severe renal dysfunction (eGFRcreat less than 30 mL/min/1.73 m2) or dialysis patients (including peritoneal dialysis) 4) Patients with severe hepatic dysfunction (AST or ALT more than 3 times the upper limit of the reference value of the performing institution) 5) Patients who have been certified as physically disabled 6) Patients who have had implant surgery for orthopaedic disorders 7) Patients whose symptoms of pain, etc. caused by orthopaedic disorders are not under control 8) Patients who have a history of cerebral or myocardial infarction with paralysis or heart failure with in 6 months prior to registration 9) Patients with a pacemaker 10) Patients allergic to 5-aminolevulinic acid (5-ALA) 11) Patients with porphyria 12) Patients with drug hypersensitivity such as iron allergy 13) Patients taking healthy foods or dietary supplements expected to be effective against sarcopenia and/or locomotive syndrome, or healthy foods or dietary supplements containing ALA, iron, or zinc as the main ingredients 14) Other conditions deemed inappropriate by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to 24 weeks post-intervention in 5 times sit to stand test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Lower limb muscle strength 2) Grip strength (dominant hand, right hand, left hand, left-right average) 3) Skeletal muscle mass index (SMI) 4) Gait speed 5) Short Physical Performance Battery (SPPB) 6) Lower leg circumference (maximum diameter) 7) Body weight 8) Body Mass Index (BMI) 9) Basal metabolic expenditure 10) Activity level 11) EQ-5D-5L (EuroQol 5 Dimension 5-levels) 12) Kihon Checklist (KCL) | — |
Contacts
Public ContactKen Sugimoto
KAWASAKI GERIATRIC MEDICAL CENTER
Outcome results
None listed