Tokyo, Sept. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056580) titled 'Effects of a test food on skin conditions' on Sept. 25.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - N/A(healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to examine effects of a test food on skin conditions.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of a test food for 8 weeks
Interventions/Control_2 - Oral ingestion of a placebo food for 8 weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Female
Key inclusion criteria - 1)Japanese women aged 30-59 years.
2)Individuals who are healthy without chronic physical illness, including skin diseases.
3)Individuals who are concerned about skin dryness.
4)Individuals whose written informed consent has been obtained.
5)Individulals who can visit an inspection facility and be inspected in designated days.
6)Individuals judged appropriate for the study by the principal.
Key exclusion criteria - 1) Individuals using medical products.
2) Individuals who have or are being treated for skin disease symptoms.
3) Individuals with wounds or inflammation at the skin measurement points.
4) Individuals with a history of serious liver, kidney, heart, lung, or blood disease.
5) Individuals with a history of serious gastrointestinal disease.
6) Individuals with alcoholism or a mental illness.
7) Individuals who used or applied medications for disease treatment in the past 1 month.
8) Individuals who may not control seasonal allergy symptoms with regular medications during the trial.
9) Individuals with food allergies.
10) Individuals with serious anemia.
11) Individuals who smoke.
12) Individuals who are or may be pregnant, or lactating.
13) Individuals whose lifestyle will change during the trial.
14) Individuals who will get sunburned during the trial.
15) Individuals who had a habit of ingesting foods for specified health uses or supplements containing ingredients of the test food in the past 3 months or will ingest them during the trial.
16) Individuals who had a habit of ingesting foods for specified health uses or supplements that improve skin condition in the past 3 months or will ingest them during the trial.
17) Individuals who had a habit of ingesting or applying pharmaceuticals, quasi-drugs, or cosmetics likely to affect the trial in the past 3 months.
18) Individuals who conducted hormone replacement therapy in the past 6 months.
19) Individuals who received special facial care at external institutions currently or within the past 6 months.
20) Individuals who received cosmetic medicine in the past 6 months.
21) Individuals who were hospitalized and received treatment in the past 6 months.
22) Individuals who participated in other clinical studies within one month of consent for this study or plan to participate in other clinical studies.
23) Individuals judged inappropriate for the study by the principal.
Target Size - 86
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 11 Month 14 Day
Date of IRB - 2024 Year 11 Month 14 Day
Anticipated trial start date - 2025 Year 01 Month 14 Day
Last follow-up date - 2025 Year 04 Month 03 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064440
Disclaimer: Curated by HT Syndication.
