5-AminoLevulinic Acid as anti-sarcopenia Diet; study of efficacy and Dose dependency IN sarcopenia patients

JRCT ID: jRCTs031200433

Registered date:22/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: sarcopenia
• Date of first enrollment: 19/05/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Group A: administer 2 capsules of study food 1 (including ALA 50mg, SFC 29mg, and high zinc yeast 50mg per 2 capsules) per day (1 capsule at morning and 1 capsule at evening).
Group B: administer 2 capsules of study food 2 (including ALA 100mg, SFC 29mg, and high zinc yeast 50mg per 2 capsules) per day (1 capsule at morning and 1 capsule at evening).
Group C: administer 2 capsules of study food 3 (including ALA 150mg, SFC 29mg, and high zinc yeast 50mg per 2 capsules) per day (1 capsule at morning and 1 capsule at evening).
Group D: administer 2 capsules of study food 4 (including ALA 100mg, SFC 57mg, and high zinc yeast 50mg per 2 capsules) per day (1 capsule at morning and 1 capsule at evening).
Group E: administer 2 capsules of study food 5 (placebo) (including ALA 0mg, SFC 29mg, and high zinc yeast 50mg per 2 capsules) per day (1 capsule at morning and 1 capsule at evening).

Outcome(s)

• Primary Outcome: Change in skeletal muscle index (SMI, kg/m2) measured by bioimpedance analysis (BIA) from baseline to week 12

Secondary Outcome

1. body weight
2. BMI
3. SMI (kg/m2) measured by BIA
4. basal metabolic rate
5. grip power
6. lower leg circumference
7. physical activity (METs)
8. 6m walking speed
9. Five-times-sit-to-stand test
10. SPPB (Short Physical Performance Battery)
11. SF-36 (MOS 36-Item Short-Form Health Survey)
12. BDI (Beck Depression Inventory)
13. EQ-5D (EuroQol 5 Dimension)

Key inclusion & exclusion criteria

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

Include criteria

1. Male and female aged 65 years or older at giving their consent
2. male and female whose walking speed is less than 1m/sec, male whose grip power is less than 25kg, or female whose grip power is less than 20kg at giving their consent
3. Subjects whose BMI is less than 18.5 kg/m2, male whose lower leg circumference is less than 34cm, or female whose lower leg circumference is less than 33cm at giving their consent
4. male whose skeletal muscle index (SMI, kg/m2) measured by bioimpedance analysis (BIA) is less than 7.0kg/m2, or female whose SMI measured by BIA is less than 5.7kg/m2 at giving their consent
5. Subjects who provide their consent in a written form by themselves

Exclude criteria

1. Subjects with rheumatism
2. Subjects with 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 who need legal representative for giving consent
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 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.