Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062853) titled 'Exploratory study on multifaceted health values of test food' on Sept. 9.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kewpie Jyozo Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of 4-week continuous intake of test food on skin moisture, bowel movements, fatigue, and diet-related urinary markers (such as indoxyl sulfate) in men and women aged 22 to 64 years old. The purpose is to identify optimal outcomes for subsequent confirmatory randomized controlled trials through this exploratory study and contribute to formulating market strategies that maximize the health value of test food.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Daily intake of 15 mL (once a day) of test food for 4 weeks (dilution with water etc. is permitted, no specified timing).
Eligibility:
Age-lower limit - 22
years-old
Gender - Male and Female
Key inclusion criteria - 1) Persons who received a sufficient explanation of the purpose and contents of the study, applied voluntarily with sufficient understanding, and agreed to participate in the study with written consent.
2) Healthy Japanese male and female persons who are 22 years old or more and under 65 years old at the time of obtaining consent.
Key exclusion criteria - 1) Persons who have chronic illness and receive medication, or have a serious disease history (except those judged by the supervising physician or principal investigator to have no issues).
2) Persons who have skin diseases (such as atopic dermatitis).
3) Persons who easily develop symptoms such as diarrhea or abdominal pain (weak gastrointestinal tract).
4) Persons who have food allergies to the test food.
5) Persons who are participating in other clinical studies.
6) Persons who are pregnant, may be pregnant, or are breastfeeding.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 24 Day
Date of IRB - 2026 Year 08 Month 27 Day
Anticipated trial start date - 2026 Year 09 Month 14 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=R000071955
Disclaimer: Curated by HT Syndication.
