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Safety test of the food

Pediatric safety test of processed foods from plant: An exploratory clinical trial - Safety test of the food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052794
Enrollment
40
Registered
2023-11-17
Start date
2023-11-20
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 listed

Interventions

Intake the processed foods from plant once a day for 8wks. No intake

Sponsors

Juntendo University School of Medicine Juntendo Clinic
Lead Sponsor
C&amp
Collaborator
C Qualitative Interview Institute, Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants aged 1-3 2. Infants for whom written consent to participate in this study has been obtained from parent/guardian 3. Infants whose parents have a history of allergic diseases (food allergy, bronchial asthma, atopic dermatitis, allergic rhinitis or hay fever, conjunctivitis, etc.) in the past

Exclusion criteria

Exclusion criteria: 1. Infants currently suffering from infections that are presumed to interfere with study performance, such as dyskeratosis, blistering, pneumonia, and certain viral infections 2. Infants who have been diagnosed by a physician as having an allergic disease (food allergy, bronchial asthma, atopic dermatitis, allergic rhinitis or hay fever, conjunctivitis, etc.) in the past 3. Infants born at a gestational age of less than 37 weeks 4. Infants who has low birth weight (<2500g) 5. Multiple fetuses 6. Infants who have had allergic reactions in the past to amanino, sesame, or other edible oils 7. Infants with a habit of continuous consumption of amani-oil and sesame oil 8. Infants whom the principal researcher or researcher in charge determines to be inappropriate as subjects of the study

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events during the period of consumption of the test food (excluding adverse events determined to be poorly related to the consumption of the test food)

Secondary

MeasureTime frame
-TEWL value -Stratum corneum moisture content -Skin surface image -Skin color image -Blood test

Countries

Japan

Contacts

Public ContactYuki Shimizu

Kao Corporation Biological Science Research Lab.

shimizu.yuki4@kao.com+81-80-7614-3911

Outcome results

None listed

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