Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract

Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract - Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038492

Enrollment

Registered

2019-11-05

Start date

2019-11-15

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

Healthy

Interventions

Subjects receive 15 mg/day of 5-aminolevulinic acid phosphate, 1.8 mg/day of Fe, and 0.3 mg/day of salacinol for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Healthy 2) A 75 g Oral glucose tolerance test is <140 mg/dL, or 140<= and <200 mg/dL 3) Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Taking medicines for chronic disease 2) Taking functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) Judged as ineligible by clinical investigators

Design outcomes

Primary

Measure	Time frame
Adverse events including laboratory abnormality and the changes in CTCAE grade	—

Countries

Japan

Contacts

Public ContactFumiko Higashikawa

Graduate School of Biomedical and Health Sciences, Hiroshima University Department of Probiotic Science for Preventive Medicine

funcfood@hiroshima-u.ac.jp082-257-1533

Outcome results

None listed

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