Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063203) titled 'A Study on the Effects of Intake of the Test Food on Skin Conditions' on Oct. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Macromill Carenet, Inc.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of 8-week continuous intake of the test food on skin conditions in healthy adult men and women concerned about skin dryness through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Continuous intake of the test food for 8 weeks
Interventions/Control_2 - Continuous intake of the placebo food for 8 weeks
Eligibility:
Age-lower limit - 35
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy Japanese men and women aged 35 to 64 years at the time of providing informed consent.
(2) Individuals concerned about skin dryness.
(3) Individuals who have received a sufficient explanation of the purpose and content of the study, have the capacity to provide consent, fully understand the content, and can provide personal consent via electronic informed consent.
Key exclusion criteria - (1) Persons with skin disease symptoms.
(2) Persons with wounds or inflammation on evaluation sites.
(3) Persons who consume foods that may affect the test results, or who are unable to restrict or discontinue their intake during study.
(4) Persons planning to change basic cosmetics on evaluation sites during study.
(5) Persons with cosmetic procedures on evaluation sites within 12 weeks prior to visit screening 1, and unable to refrain.
(6) Persons consuming health foods/FHC/FFC, or unable to stop.
(7) Persons with severe medical history or chronic disease under medical treatment/medication.
(8) Persons taking medications affecting test results.
(9) Persons with severe history of cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine diseases.
(10) Persons with severe history of GI surgery.
(11) Persons with risk of severe food allergies.
(12) Persons with significant test abnormalities at visit screening.
(13) Persons with risk of seasonal allergies using drugs during study.
(14) Persons with history of feeling unwell during blood collection.
(15) Blood donors: 200 mL within 4 weeks or component within 2 weeks; 400 mL within 16 weeks (women) or 12 weeks (men).
(16) Excessively sunburned persons, or unable to refrain from direct sunlight.
(17) Current smokers, or non-smokers who smoked within 3 months prior to study start.
(18) Habitual drinkers.
(19) Persons with extremely irregular sleep/dietary habits.
(20) Persons whose living, dietary, or exercise habits may change significantly.
(21) Women lactating, pregnant, possibly pregnant, or planning pregnancy.
(22) Participants in other trials currently, within 4 weeks prior to screening 1, or during study.
(23) Others deemed ineligible by the principal investigator.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 30 Day
Anticipated trial start date - 2026 Year 11 Month 01 Day
Last follow-up date - 2027 Year 02 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072286
Disclaimer: Curated by HT Syndication.
