Tokyo, Dec. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059929) titled 'Study of the effects of food ingredients on skin' on Dec. 14.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Suntory Beverage & Food Limited
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of food ingredients on skin
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of the test foods for 12 weeks.
Interventions/Control_2 - Intake of the control foods for 12 weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy men and women who are between 20 and 59 years old from the time of consent to participate in the study until the end of the study.
(2) Subjects who are able to attend the designated facility on the scheduled visit date.
(3) Subjects who are aware of dry skin.
(4) Subjects who have fully understood the purpose and content of this study and have given their consent.
Key exclusion criteria - (1) Subjects with a systolic blood pressure of less than 90 mmHg
(2) Subjects wishing pregnancy, pregnant or lactating during the study.
(3) Subjects participating in other study or participated within the past 4weeks, or are planning to participate in another clinical trial during the study.
(4) Subjects who fall under any of the following categories:
a) disease on heart, liver, kidney or other organs complications
b) having a history of cardiovascular disease
c) diabetes
d) allergic to the test foods or prescribed diet
e) having a history of serious diseases such as cancer or tuberculosis
f) symptoms of inflammatory skin diseases
(5) Smokers or those who have quit smoking for less than 6months.
(6) Subjects who heavy use of alcohol.
(7) Subjects with extremely irregular eating habits.
(8) Subjects whose lifestyles may become irregular during the study.
(9) Subjects whose assessment areas are deemed difficult to measure.
(10) Subjects who have undergone surgery in the assessment areas within the past year.
(11) Subjects who currently or in the past 3months have been taking or applying medications, quasi-drugs, or cosmetics for the purpose of treating a medical condition.
(12) Subjects who may develop seasonal allergies such as hay fever during the study period and may use medications.
(13) Subjects who currently or within the past three months have taken or are planning to take or apply health foods, foods for specified health uses, pharmaceuticals, quasi-drugs, or cosmetics that may affect the evaluation results, or who plan to do so during the study.
(14) Subjects who regularly engage in sunburn-inducing activities.
(15) Subjects who have undergone any medical procedure or treatment within the past 3months that may affect the evaluation area.
(16) Females with irregular menstrual cycles at the consent.
(17) Females with significant skin irritation during menstruation.
(18) Others who are judged inappropriate for participant by the investigator.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 01 Day
Anticipated trial start date - 2025 Year 12 Month 14 Day
Last follow-up date - 2026 Year 05 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068516
Disclaimer: Curated by HT Syndication.
