Safety evaluation study of overdose of test food in healthy adults

Safety evaluation study of overdose of test food in healthy adults - Safety evaluation study of overdose of test food in healthy adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050091

Enrollment

Registered

2023-01-20

Start date

2023-01-24

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 Adults

Interventions

Consume 5 tablets of the test food daily for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Japanese who are 18 years old or more and under 65 years old

Exclusion criteria

Exclusion criteria: 1. Persons who have chronic illness, receiving medication, have a serious disease history 2. Persons who are allergic to the test food 3. Persons who regularly take a large amount of the test food 4. Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect blood test values, urine test values, and blood pressure 5. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 6. Persons who were judged as inappropriate for study participants by the principal investigator 7. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding

Design outcomes

Primary

Measure	Time frame
Adverse event rate	—

Secondary

Measure	Time frame
Blood test (white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, total protein, albumin, triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol, AST (GOT), ALT (GPT), ALP, gamma -GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chloride, calcium, phosphorus, magnesium, LDH, glucose) Urinalysis (urine protein qualitative, urinary glucose qualitative, urinary PH, urinary occult blood test) Physical examination (height, weight, BMI, blood pressure)	—

Measure

Time frame

Blood test (white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, total protein, albumin, triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol, AST (GOT), ALT (GPT), ALP, gamma -GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chloride, calcium, phosphorus, magnesium, LDH, glucose) Urinalysis (urine protein qualitative, urinary glucose qualitative, urinary PH, urinary occult blood test) Physical examination (height, weight, BMI, blood pressure)

—

Countries

Japan

Contacts

Public ContactTakamasa Masuda

Healthcare Systems Co., Ltd. Clinical Research Department

masudat@hc-sys.jp0368092722

Outcome results

None listed

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