Tokyo, Jan. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060288) titled 'A Study on the Effects of the Test Food on Skin -A Randomized, Double-blind, Placebo-controlled Parallel-group Study-' on Jan. 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Morishita Jintan Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of continuous 8-week intake of the test food on skin in healthy adults.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test food (1 pack a day, 8weeks)
Interventions/Control_2 - Consumption of the placebo food (1 pack a day, 8 weeks)
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1) Premenopausal women aged 20-64 years
2) Subjects with constipation tendencies having mainly 3-5 bowel movements per week at the time of screening
3) Subjects who have a regular diet (three meals a day (breakfast, lunch, and dinner ))
4) Subjects who are concerned about drying of the skin as subjective symptoms
5) Subjects who use only one or two items of skin care products, such as lotion and emulsion, after daily face washing
6) Subjects who have received a sufficient explanation regarding the purpose and details of this study, are capable of providing informed consent, fully understand the information provided, and voluntarily agree in writing to participate in this study
Key exclusion criteria - 1) Subjects who meet the diagnostic criteria for chronic constipation in the clinical guidelines for chronic constipation 2023
2) Subjects who regularly consume large amounts of foods containing active ingredient, or health foods containing active ingredient
3) Subjects who regularly take medications, including intestinal regulators, laxatives, and purgatives (regulators are permissible if discontinued from screening to study end)
4) Subjects with severe liver, kidney, digestive, heart, respiratory, endocrine, thyroid, adrenal diseases, or other metabolic disorders (excluding transient conditions such as the common cold)
5) Subjects who have a digestive disease that affects digestion and absorption, or a history of surgery (excluding appendicitis)
6) Subjects who have a history or current medical history of drug dependence or alcoholism
7) Subjects who are diagnosed with chronic constipation
8) Subjects who are unable to stop taking health foods or supplements (including FOSHU/FFC) that may affect this study
9) Subjects who have a habit of drinking excessively (>= 20g pure alcohol eq./day, >= 4 days/week)
10) Subjects who have a habit of smoking excessively (>= 21 cigarettes/day)
11) Shift worker or night-shift worker (excluding daytime shift work)
12) Subjects who plan to travel overseas or domestic long-term for personal or business purposes (> 10 days/month), or be transferred during this study
13) Subjects who have donated > 200 mL blood/component blood within one month or > 400 mL within three months prior to screening test
14) Subjects who consume yogurt, lactic acid bacteria, or bifidobacteria-containing foods >= 3 times/week, or unwillingness to refrain during the study
15) Subjects who have any factors on the skin of the evaluation site that may affect the test results (such as diseases like urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, or their traces)
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 30 Day
Date of IRB - 2025 Year 11 Month 06 Day
Anticipated trial start date - 2026 Year 01 Month 12 Day
Last follow-up date - 2026 Year 04 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068681
Disclaimer: Curated by HT Syndication.
