Safety Evaluation Study of 12-Week Continuous Intake of Egg-Derived Ingredient-Containing Food: A Single-Arm, Pre-Post Comparison Study (Open-Label Study)

Safety Evaluation of a 12-Week Continuous Intake of an Egg-Derived Ingredient-Containing Food: A Single-Arm, Pre-Post Comparison Study (Open-Label Study) - A 12-week safety study of food containing egg-derived ingredients in healthy adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061474

Enrollment

Registered

2026-05-07

Start date

2026-04-16

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

Subjects will consume 6 tablets of the test food (containing a specific egg-derived ingredient) once daily at breakfast with water for 12 consecutive weeks (84 days).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Japanese male and female adults. Subjects who have provided voluntary written informed consent after receiving a thorough explanation of the study and fully understanding its nature. Subjects judged to be suitable for the study by the investigator or sub-investigator.

Exclusion criteria

Exclusion criteria: Food Allergies: Subjects with known food allergies to the ingredients of the test food (e.g., eggs, soybeans). Medical History: Subjects with serious heart, liver, renal, or gastrointestinal diseases, or a history of such conditions. This includes subjects with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2, calculated from recent health check-up results (creatinine levels) provided by the subject. Medications: Subjects habitually taking medications that may affect blood parameters or gut microbiota composition (e.g., antibiotics, medications for dyslipidemia, or diabetes). Non-compliance: Subjects judged to have difficulty adhering to the study requirements (e.g., 12-week continuous intake of the test food, consumption of the standardized meal, and the prescribed fasting period prior to measurements). Hormonal Preparations: Females habitually using hormonal preparations, such as oral contraceptives. Investigator's Judgment: Others judged to be unsuitable for participation in the study by the principal investigator or the physician.

Design outcomes

Primary

Measure	Time frame
1.Clinical laboratory parameters (hematology, blood chemistry, and urinalysis) for safety assessment. 2.Changes from baseline in specific blood metabolites and gut microbiota composition. 3.Evaluation of dietary habits, nutrient intake, and lifestyle patterns using validated questionnaires.	—

Countries

Japan

Contacts

Public ContactYui/ Wei Ou/Wang

Kewpie Corporation R&D Division

yui_ou@kewpie.co.jp03-5384-7759

Outcome results

None listed

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