Tokyo, Feb. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060732) titled 'A study to examine the effects of test food intake on skin function' on Feb. 23.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - rosavista Co., Ltd.
Condition:
Condition - Healthy volunteer
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this trial is to conduct human testing and evaluate the effects on the skin of continuous consumption of 'To-jun', a food product developed by Rosavista Co., Ltd. containing mulberry leaf extract, tobi fruit peel extract, and acetic acid bacteria ferment.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consume the test food.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1) Women aged 20 years or older but under 70 years at the time of obtaining consent to participate in the trial
2) Healthy individuals without chronic physical illnesses
3) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, have fully understood the information, voluntarily wish to participate, and can provide written consent to participate in this trial
4) Individuals who can attend the centre on the designated examination date and undergo the examination
5) Individuals deemed suitable for participation in this trial by the principal investigator
Key exclusion criteria - 1) Individuals currently suffering from any disease and undergoing drug treatment
2) Individuals with a history or current condition of impaired glucose tolerance, mental illness, sleep disorders, hypertension, diabetes, hyperlipidaemia, or other serious diseases
3) Individuals with a history of regular medication use within the past month for disease treatment (excluding occasional use for headaches, menstrual pain, colds, etc.)
4) Individuals with a history or current condition of severe impairment of the liver, kidneys, heart, lungs, blood, etc.
5) Individuals with concomitant diseases or a history of diseases of the digestive organs (excluding a history of appendicitis)
6) Individuals with a BMI of 30 kg/m2 or above
7) Individuals at risk of developing allergic reactions to the test food, or those at risk of severe allergic reactions to other foods or medicines
8) Individuals who have donated blood exceeding 200 mL within the past month, or 400 mL within the past three months
9) Individuals with severe anaemia
10) Individuals who are pregnant, breastfeeding, or who may be pregnant
11) Individuals who currently have, or have had within the past three months, a habit of continuously consuming functional foods or health foods marketed for skin quality improvement, or who plan to consume such products during the trial period (consumption for general health maintenance is permissible)
12) Individuals with photosensitivity
13) Other individuals deemed unsuitable for this trial by the principal investigator
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 29 Day
Date of IRB - 2026 Year 02 Month 10 Day
Anticipated trial start date - 2026 Year 02 Month 16 Day
Last follow-up date - 2026 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069359
Disclaimer: Curated by HT Syndication.
