Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059532) titled 'Verification of the Effects of Lactic Acid Bacteria Consumption on the Skin Quality of Healthy Individuals Who Recognize Having Sensitive Skin
-A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study-' on Sept. 30.
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 (lactic acid bacteria-containing 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 with sensitive skin symptoms.
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 or current condition of serious disorders affecting the digestive organs, liver, kidneys, heart, lungs, blood, or mental health.
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 lactic acid bacteria-enriched foods, foods for specified health uses claiming skin improvement effects, foods with functional claims, or health foods.
9) whose average weekly alcohol consumption exceeds 40 g/day for men or 20 g/day for women, converted to pure alcohol.
10) with a smoking habit
11) who may have night shifts or changes in lifestyle habits during the trial period.
12) who may experience symptoms such as itching on the evaluation sites (face, arms, back) due to seasonal allergy symptoms like hay fever during the trial period. Also, individuals who may take anti-allergy medications or use nasal sprays (eye drops are acceptable).
13) unable to refrain from intentional exposure to direct sunlight, such as sunbathing, during the trial period.
14) with a history of cosmetic procedures or treatments on the evaluation sites within the past 6 months.
15) who are pregnant, breastfeeding, or may become pregnant during the trial period.
16) currently participating in another human clinical trial, or individuals who have not completed participation in another human clinical trial within the past 3 months.
17) Other individuals deemed ineligible for this trial by the principal investigator.
Target Size - 100
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 09 Month 24 Day
Date of IRB - 2025 Year 09 Month 25 Day
Anticipated trial start date - 2025 Year 12 Month 25 Day
Last follow-up date - 2026 Year 03 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067765
Disclaimer: Curated by HT Syndication.
