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ALASAP STUDY

Study on the effect of aminolevulinic acid, a natural amino acid which controls mitochondria in the skeletal muscle, on physical performance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190094
Enrollment
54
Registered
2019-09-12
Start date
2020-02-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

none

Interventions

Group A: aminolevulinic acid administration group Administration method: Subjects take 2 capsules per day, which contains 50 mg 5-aminolevulinic acid phosphate and 29 mg ferrous citrate Administration

Sponsors

Kinouchi Kenichiro
Lead Sponsor
Ito Hiroshi
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male aged >= 20 and < 80 years 2. Subjects whose grip power in better side is 26-40kg 3. Subjects who provide written consent form to participate in this study by their own free will after full explanation of the study

Exclusion criteria

Exclusion criteria: 1. Subjects with history of hypersensitivity against aminolevulinic acid, or those who meet the contraindication for aminolevulinic acid 2. Subjects with diabetes mellitus whose HbA1c is >= 9.0%, or subjects with chronic kidney disease whose eGFR is < 30 3. Subjects with uncontrolled psychiatric disorder 4. Subjects who cannot provide written consent form, who cannot understand the outline and purpose of the study, or who need legal representatives 5. Subjects who are considered to be unsuitable for participation by attending physicians

Design outcomes

Primary

MeasureTime frame
Change of handgrip from baseline to week 12

Secondary

MeasureTime frame
Chang e of following items from baseline to week 12 1. lower limb muscle strength (knee extension muscle strength) 2. walking speed (5m walking time) 3. 5 times sit to stand test (SS-5) 4. muscle mass (bioelectrical impedance analysis) 5. fat mass (bioelectrical impedance analysis) 6. lower leg circumference (at max circumference) 7. body weight 8. HbA1c 9. high sensitivity CRP (hsCRP)

Contacts

Public ContactKazutoshi Miyashita

Keio University Hospital

miyakaz@z6.keio.jp+81-3-5363-3796

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026