Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056326) titled 'Preliminary study of the Effects of Test Food Intake on Skin Quality Improvement' on Nov. 30.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This preliminary study is conducted to verify the skin quality improvement effects of the test food, in preparation for future planned trials.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral consumption of one sachet of the test food dissolved in hot water once daily for 8 weeks.
Eligibility:
Age-lower limit - 35
years-old
Gender - Female
Key inclusion criteria - 1. Female aged 35 to below 65 years at the time of consent acquisition.
2. Individuals who are aware of having dry skin.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who regularly consume Food for Specified Health Uses (FOSHU), functional foods, or health supplements (including those containing collagen, sodium hyaluronate, glucosyl ceramide, etc.) more than three times a week.
2. Individuals who cannot discontinue the intake of Food for Specified Health Uses (FOSHU), functional foods, or health supplements (including those containing collagen, sodium hyaluronate, glucosyl ceramide, etc.) from the time of consent.
3. Individuals using medications that could affect the trial outcomes, such as heparin analogs, urea, vaseline, or topical steroids.
4. Individuals with scars, bruises on measurement sites (left cheek, inner left forearm).
5. Individuals with skin irritation due to hay fever.
6. Individuals with extreme sunburn or those who engage in outdoor labor, work, or sports for extended periods.
7. Individuals planning a long-term overseas trip from the pre-test period through the end of the study.
8. Individuals receiving special care at external facilities for skin measurement areas (facial or body aesthetics, beauty devices, peeling, laser treatments, hair removal, etc.).
9. Individuals with excessive alcohol intake.
10. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
11. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
12. Individuals with allergies to medications and/or food.
13. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
14. Individuals who donated 200 mL of their blood or blood components within the last month.
15. Individuals who donated 400 mL of their blood within the last 4 months.
Target Size - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 11 Month 18 Day
Date of IRB - 2024 Year 11 Month 15 Day
Anticipated trial start date - 2024 Year 12 Month 01 Day
Last follow-up date - 2025 Year 04 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063892
Disclaimer: Curated by HT Syndication.
