Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061474) titled 'Safety Evaluation Study of 12-Week Continuous Intake of Egg-Derived Ingredient-Containing Food: A Single-Arm, Pre-Post Comparison Study (Open-Label Study)' on May 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Kewpie Corporation

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the safety and exploratory efficacy of a 12-week continuous intake of an egg-derived ingredient-containing food by assessing various blood metabolite markers, clinical laboratory parameters (hematology, blood chemistry, etc.), and gut microbiota in healthy adults. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - 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: Age-lower limit - 20 years-old

Gender - Male and Female Key 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. Key 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. Target Size - 10

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 03 Month 27 Day Date of IRB - 2026 Year 04 Month 16 Day Anticipated trial start date - 2026 Year 04 Month 16 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070343

Disclaimer: Curated by HT Syndication.