Tokyo, Aug. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058897) titled 'A placebo-controlled randomized double-blind parallel-group comparison study on the effects of continued intake of collagen peptides on the skin and scalp' on Aug. 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Miura Clinic, Medical Corporation Kanonkai
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate the effects on skin and scalp by continuously ingestion of test food for 12 weeks
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of test food for 12 consecutive weeks
Interventions/Control_2 - Intake of control placebo food for 12 consecutive weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy men and women aged 20 to 64
(2) Individuals with dry skin and scalp
(3) Individuals who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
Key exclusion criteria - (1) Individuals with a history of mental illness, diabetes, liver disease, renal diseases, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease.
(2) Individuals who have undergone gastrointestinal surgery.
(3) Individuals showing abnormal liver and kidney function test values.
(4) Individualswith a current medical condition.
(5) Individuals with skin symptoms.
(6) Individuals who are allergic to food and drugs.
(7) Individuals with symptoms of anemia.
(8) Females wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects.
(9) Individuals who participate in strenuous sports and subjects who are trying to lose weight.
(10) Individuals with extremely irregular eating habits.
(11) Individuals who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the study period.
(12) Individuals who are continuously treated with medications (including OTC, prescription drugs).
(13) Individuals who drink more than 40 g of average daily pure alcohol.
(14) Individuals who smoke an average of 21 or more cigarettes a day.
(15) Individuals who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study.
(16) Individuals judged by the principal investigator or the associate investigator to be inappropriate for the examination.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 20 Day
Date of IRB - 2025 Year 08 Month 21 Day
Anticipated trial start date - 2025 Year 08 Month 28 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067341
Disclaimer: Curated by HT Syndication.