Potency of 5-AminoLevulinic Acid phosphate as anti-sarcopenia Diet IN Japanese patients with sarcopenia: multicenter, double-blinded, randomized-controlled trial

JRCT ID: jRCTs031240336

Registered date:17/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sarcopenia
• Date of first enrollment: 17/09/2024
• Target sample size: 160
• Study type: Interventional

Intervention(s)

Study food intake group:
Intake study foods (including ALA 100mg, SFC 29mg, and high zinc yeast 50mg per capsule) once daily for 24 weeks.

Placebo intake group:
Intake placebo foods (including ALA 0mg, SFC 0mg, and high zinc yeast 0mg per capsule) once daily for 24 weeks.

Outcome(s)

• Primary Outcome: Change in hand grip of dominant hand from baseline to week 24

Secondary Outcome

Measurement at each observation point and change from baseline to each observation point in following items;
1. Hand grip (dominant hand, right hand, left hand, avarage of right and left hands) (except the primary endpoint)
2. Skeletal muscle mass index measured by bioimpedance analysis method
3. SPPB (Short Physical Performance Battery)
4. 5-repetition sit-to-stand test (5STS)
5. 4m walking distance
6. Balance test
7. lower leg circumference
8. SARC-F
9. Body weight
10. BMI (body mass index)
11. Basal metabolic rate
12. Number in steps
13. EQ-5D-5L (EuroQol 5 Dimension 5-levels)
14. Basic frail checklist
15. DASC-8
16. OABSS

Key inclusion & exclusion criteria

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

Include criteria

Subjects who meet all of the following criteria are included in this study;
1. Subjects who meet the following criteria i and iii, or ii and iii
i. Subjects whose walking speed is less than 1.0m/sec or whose result in 5-repetition sit-to-stand test (5STS) is 12 sec or longer in general medical practice
ii. Male whose hand grip is less than 28kg, or female whose hand grip is less than 18kg in general medical practice
iii. Male whose skeletal muscle mass index (SMI) measured by bioimpedance analysis (BIA) method was less than 7.0 kg/m2, or female whose SMI measured by BIA method was less than 5.7 kg/m2
2. Male and female aged 65 years or older at giving their consent
3. Subjects who provide their consent in a written form by themselves

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study;
1. Subjects with chronic rheumatoid
2. Subjects who are diagnosed with dementia and are receiving treatment for dementia
3. Subjects with severe renal dysfunction (whose eGFRcreat is less than 30mL/min/1.73m2) or subjects who are treated by dialysis
4. Subjects with severe hepatic dysfunction (whose AST or ALT is 3 times or more higher than the upper limit of normal at the study execution medical institution)
5. Crippled subjects
6. Subjects with history of cerebral infarction or myocardial infarction
7. Subjects with pacemaker
8. Subjects with allergy against 5-aminolevulinic acid
9. Subjects with porphyria
10. Subjects with drug hypersensitivity, such as allergy against iron
11. Subjects who are taking healthy foods that are expected to have effects on sarcopenia or healthy foods or medical agents containing ALA, iron, or zinc
12. Subjects with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study

Related Information

• Primary Sponsor: Tamura Yoshifumi
• Secondary Sponsor: Watada Hirotaka
• Source(s) of Monetary Support: SBI Pharmaceuticals Co., Ltd.