UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049702 |
|---|---|
| Receipt number | R000056179 |
| Scientific Title | Verification of improvement effects on skin function by test-food consumption |
| Date of disclosure of the study information | 2023/09/12 |
| Last modified on | 2024/06/12 15:38:24 |
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Basic information
Public title
Verification of improvement effects on skin function by test-food consumption
Acronym
Verification of improvement effects on skin function by test-food consumption
Scientific Title
Verification of improvement effects on skin function by test-food consumption
Scientific Title:Acronym
Verification of improvement effects on skin function by test-food consumption
Region
| Japan |
Condition
Condition
Healthy female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether test-food intakes for twelve weeks can reveal some kind of improvement effect on skin function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Moisture-retention function
transcutaneous moisture-evaporating capacity (left temple, and left forearm inside (2P)), and stratum corneum moisture-binding capacity (left temple, and left forearm inside (2P))
Key secondary outcomes
1. Skin viscoelasticity (left temple, and left forearm inside (2P))
2. VISIA TM Evolution (blotch, wrinkle, pores, color irregularity, hiding blotch, porphyrin, melanin-index, and hemoglobin-index)
3. Skin questionnaire
4. Oxidative stress degree test (thiobarbituric acid-reactive substances)
5. Blood ergothioneine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food (21 drops/day) for twelve weeks.
Interventions/Control_2
Ingestion of the placebo food (21 drops/day) for twelve weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy female subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects who feel their skin dryness, skin roughness, and so on.
(3) Subjects who can give informed consent to partake in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) who take steadily (over 3 times a week) in affecting health-specific/functional/supplementary/health foods,
(2) who have taken affecting medicines and quasi-ones (e.g., skin medicine for external use), over 3 times a week, and have any difficulty in refraining from taking them,
(3) with excessive suntan, or planning to tan on trips, events, etc.,
(4) planning to change their cosmetics,
(5) planning to newly begin their skin cares,
(6) suffering from some kind of skin disease (e.g., atopic dermatitis),
(7) having a bruise and/or a hurt near the skin-measuring position,
(8) who are now under a specific care near the skin-measuring position (e.g., facial treatment, electric facial, peeling, body care, laser therapy, and hair removal) at an outside agency,
(9) with excessive alcohol intake,
(10) having mushrooms, over 5 days a week,
(11) having livers, over 5 days a week,
(12) being poor at mushrooms,
(13) having their skin roughness due to pollinosis,
(14) who realized being in a failing skin condition by menstruation,
(15) having an irregular life rhythm with irregular shift work or midnight one,
(16) being under other clinical tests with medicine or health food, or partook in those within four weeks to this trial, or planning to join those after giving informed consent,
(17) planning to change their shapes of eyelashes/eyebrows,
(18) having previous/current medical history of severe cardiac, hepatic, renal or digestive diseases,
(19) with pregnancy, possibly one, or lactating,
(20) with drug and food allergy,
(21) who donated over 0.2 L of their blood and/or blood components within a month to this trial,
(22) who donated their whole blood (0.4 L) within the last four months to this trial,
(23) who will be collected in total of their blood (0.8 L) within the last twelve months, after adding the blood amounts planning to be sampled in this trial,
(24) being determined as ineligible for participation, judging from the principal/sub investigator - - .
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Hanayama |
Organization
HOKUTO Corporation
Division name
R & D
Zip code
381-0008
Address
Mushroom Research Laboratory 800-8 Oaza-Shimokomazawa, Nagano-shi, Nagano 381-0008, Japan
TEL
026-296-3211
motoki.hanayama@hokto-kinoko.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
HOKUTO Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fmed.2024.1396783/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fmed.2024.1396783/full
Number of participants that the trial has enrolled
80
Results
At 8 weeks, the skin moisture content was significantly higher on the temple in the test food group than in the placebo food group. The test food group also exhibited a significant increase in skin moisture content on the arm at 8 and 12 weeks compared with baseline. At 12 weeks, wrinkle and texture scores were significantly better in the test food group than in the placebo food group, and plasma ergothioneine (EGT) concentrations in the test food group were 4.7-fold higher than baseline.
Results date posted
| 2024 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 06 | Month | 03 | Day |
Baseline Characteristics
Healthy women aged 20 to 64 years who are aware of dry or rough skin.
Participant flow
Baseline (test food group 40, placebo food group 40)
8 weeks (test food group 38, placebo food group 39)
12 weeks (test food group 39, placebo food group 38)
Adverse events
Throughout the trial, 24 mild adverse events were reported (11 and 13 in the test food and placebo food groups, respectively). The principal investigator determined that none of these mild adverse events were related to the intake of either the test food or placebo food. No significant changes were observed in blood biochemistry analyses at 12 weeks.
Outcome measures
Transcutaneous moisture-evaporating capacity (left temple, and left forearm inside (2P)), and stratum corneum moisture-binding capacity (left temple, and left forearm inside (2P)), VISIA TM Evolution (blotch, wrinkle, pores, color irregularity, hiding blotch), Blood ergothioneine
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056179
