Tokyo, Oct. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062307) titled 'Evaluation of the Effect of Study Food Consumption on Improvement of Skin Condition' on Oct. 19.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effect of daily consumption of one serving of the test food as a replacement for a staple food per day for 8 weeks on the improvement of skin condition, compared with consumption of the control food.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral consumption of one test food once daily for 8 weeks
Interventions/Control_2 - Oral consumption of one placebo food once daily for 8 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals with a bowel movement frequency of five times or fewer per week.
3. Individuals who are concerned about dry skin.
4. Individuals who are able to receive the study food once two weeks.
5. Individuals able to consume one unit of the study food per day.
6. 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 consume Foods for Specified Health Uses, Foods with Function Claims, or other health foods or supplements more than twice a week.
Individuals who consume such products once a week or less but are unable to discontinue their use from the time of consent acquisition.
2. Individuals who consume yogurt, lactic acid bacteria drinks, or foods high in dietary fiber (e.g., brown rice, barley, whole-grain bread, cereals, and foods bearing nutrient content claim such as "contains dietary fiber" or "high in dietary fiber") a total of three or more times per week.
3. Individuals who consume alcohol more than three times per month or who consume more than 60 g of alcohol per drinking occasion.
4. Individuals who had days with fewer than 1 meal per day more than once a week within 1 month before the preliminary examination.
5. Individuals on carbohydrate-restricted, weight-loss diets or undergoing dietary therapy.
6. Individuals with extremely irregular lifestyles (e.g., night shift workers or those with irregular rotating shifts).
7. Individuals with a BMI of 30.0 kg/m2 or higher.
8. Individuals who plan to change their current lifestyle, dietary habits, living environment (e.g., moving, job transfers, overseas travel or business trips), skincare products, or cosmetics during the study period.
9. Individuals who are currently undergoing, or plan to undergo during the study period, procedures or practices that may affect skin condition, including medical treatments, aesthetic treatments, hair removal, chemical peeling, the use of microneedle-containing cosmetic products, or intentional tanning (e.g., use of tanning beds).
10. Individuals who habitually engage in prolonged sun exposure, such as outdoor sports or outdoor work.
11. 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.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 22 Day
Date of IRB - 2026 Year 06 Month 19 Day
Anticipated trial start date - 2026 Year 07 Month 23 Day
Last follow-up date - 2027 Year 01 Month 12 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070872
Disclaimer: Curated by HT Syndication.
