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A study to evaluate the safety of long-term intake of test food in healthy adult subjects

A study to evaluate the safety of long-term intake of test food in healthy adult subjects - A study to evaluate the safety of long-term intake of test food in healthy adult subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048008
Enrollment
24
Registered
2022-06-09
Start date
2022-06-13
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

Healty volunteers

Interventions

Sponsors

Pharma Foods International Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females whose age of 20 years or more and less than 65 years (2) Sujests whose BMI is 23 kg/m2 or more and less than 30 kg/m2 (3) Subjects who can make self-judgment and are voluntarily giving written informed consent

Exclusion criteria

Exclusion criteria: (1) Subjects receiving a medical treatment for chronic diseases (dyslipidemia, high blood pressure, diabetes, etc.) (2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders (3) Subjects who have the possibility of developing allergic symptoms by the test food (4) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the effects on lipid metabolism (reducing blood LDL cholesterol, triglycerides, body fat, etc.) (5) Subjects who take foods having the effects on lipid metabolism (reducing blood LDL cholesterol, triglycerides, body fat, etc.) (6) Female subjects who are pregnant or lactating, or intending to become pregnant during the study (7) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) (8) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study (9) Subjects deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
Adverse events, Side effects

Countries

Japan

Contacts

Public ContactEriko Mizuno

Soiken Inc. R&D Division

mizuno_eriko@soiken.com06-6871-8888

Outcome results

None listed

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