Tokyo, Dec. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059989) titled 'Verification of the Effect of Plant Oil Pressing Cake Extract Intake on Improving Skin Barrier Function' on Dec. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the effects of consuming the test food on skin function.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of a test food (2 tablets in a day; 8 weeks).
Interventions/Control_2 - Oral ingestion of a placebo food (2 tablets in a day; 8 weeks).
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Males and females aged 20 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals concerned about dry skin or rough skin
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria - Individuals
1)currently suffering from any disease and undergoing drug therapy.
2)undergoing hormone replacement therapy.
3)with skin disease symptoms such as atopic dermatitis.
4)with a history of ingesting or applying drugs for disease treatment within the past month.
5)with a history of serious past or current medical conditions involving the liver, kidneys, heart, lungs, blood, digestive tract, or mental disorders.
6)with a BMI of 30.0 kg/m2 or higher.
7)who may experience allergic reactions to components in the test food, or who may experience severe allergic reactions to other foods or pharmaceuticals.
8)who currently have, or have had within the past three months, a habit of continuously using specific health foods, foods with functional claims, or health supplements that promote skin improvement effects.
9)whose average weekly alcohol consumption exceeds 40 g/day for men or 20 g/day for women, converted to pure alcohol.
10)Night shift worker.
11)with a smoking habit.
12)who may have night shifts or changes in lifestyle habits during the trial period.
13)who may have allergy-related itching at the assessment site or may use antiallergic drugs or nasal sprays during the study.
14)unable to refrain from intentional exposure to direct sunlight, such as sunbathing, during the trial period.
15)who neglect skin care to an extreme degree.
16)with a history of cosmetic procedures or treatments on the evaluation site.
17)with wounds or inflammation on the evaluation site, or individuals who feel skin irritation affecting the examination occurs on the evaluation site around the time of menstruation.
18)who are pregnant, breastfeeding, or may become pregnant during the trial period.
19)currently participating in another human clinical trial, or individuals who have not completed participation in another human clinical trial within the past 3 months.
20)Other individuals deemed ineligible for this trial by the principal investigator.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 28 Day
Date of IRB - 2025 Year 10 Month 30 Day
Anticipated trial start date - 2026 Year 01 Month 21 Day
Last follow-up date - 2026 Year 03 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068246
Disclaimer: Curated by HT Syndication.
