A study of aminolevulinic acid phosphate as an aid to functional recovery in patients with sarcopenia

JRCT ID: jRCTs061240055

Registered date:13/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sarcopenia
• Date of first enrollment: 13/09/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): 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 24 weeks.

Outcome(s)

• Primary Outcome: Change from baseline to 24 weeks post-intervention in 5 times sit to stand test

Secondary Outcome

1) Lower limb muscle strength
2) Grip strength (dominant hand, right hand, left hand, left-right average)
3) Skeletal muscle mass index (SMI, kg/m2)
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)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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 (right or left) less than 28 kg for men and 18 kg for women
3. Skeletal muscle mass index (SMI) less than 7.0 kg/m2 for men and 5.7 kg/m2 for women
2) Age 65 years or older
3) Patients who have given written informed consent to participate in the study

Exclude criteria

Patients who meet any of the following categories are excluded from this study
1) Patients diagnosed with rheumatism
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 are in the hospital for treatment of knee or hip joint or have a history of surgery
7) Patients who have a history of cerebral or myocardial infarction with paralysis or heart failure within 6 months prior to registration
8) Patients with a pacemaker
9) Patients allergic to 5-aminolevulinic acid (5-ALA)
10) Patients with porphyria
11) Patients with drug hypersensitivity such as iron allergy
12) 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
13) Other conditions deemed inappropriate by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Sugimoto Ken
• Source(s) of Monetary Support: SBI Pharmaceuticals Co., Ltd.