UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056310 |
|---|---|
| Receipt number | R000064198 |
| Scientific Title | Study of the effects of test food intake on skin function and terminal glycation products |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2026/03/13 16:28:41 |
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Basic information
Public title
Study of the effects of test food intake on skin function and terminal glycation products
Acronym
Study of the effects of test food intake on skin function and terminal glycation products
Scientific Title
Study of the effects of test food intake on skin function and terminal glycation products
Scientific Title:Acronym
Study of the effects of test food intake on skin function and terminal glycation products
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of the food on skin function, terminal glycation products, and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin viscoelasticity
(Week 0, Week 6, Week 12)
Key secondary outcomes
*Secondary indexes
[1]Terminal glycation product measurement(1)
[2]Transepidermal water loss(1)
[3]Skin moisture content(1)
[4]Image analysis by VISIA(2)
[5]Observation for skin condition by dermatologists(1)
[6]Visual Analogue Scale(1)
* Exploratory endpoint
[1]Specific blood test(2)
*Safety
[1]Blood pressure, pulsation(1)
[2]Weight, body fat percentage, BMI(1)
[3]Hematologic test(1)
[4]Blood biochemical test(1)
[5]Urine analysis(1)
[6]Doctor's questions(1)
[7]Side effects/ Adverse events(3)
[8]Subject's diary(4)
(1):Week 0, Week 6, Week 12
(2):Week 0, Week 12
(3):Week 6, Week 12
(4):From the first day of ingestion of a test material to the last day of the test.
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
Oral intake of the test food (2 capsules in a day; 12 weeks).
Interventions/Control_2
Oral intake of the placebo food (2 capsules in a day; 12 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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women between 35 and 64 years of age at the time of obtaining consent to participate in the study.
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals who are aware of skin deterioration such as firmness and sagging.
4) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals undergoing hormone replacement procedures.
3) Individuals with strange skin conditions at measurement points.
4) Individuals who used a drug to treat a disease in the past 1 month.
5) Individuals who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
6) Individuals who are a patient or have a history of or endocrine disease.
7) Individuals with mental disabilities.
8) Individuals whose BMI is over 30 kg/m2.
9) Individuals who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
10) Currently, or within the past 3 months, those who have or will take medicines or health foods with claims of skin improvement or anti-glycation effects on a regular basis during the study period.
11) Individuals who excessively take alcohol.
12) Individuals who are a smoker.
13) Individuals who engage in a night work.
14) Individuals with possible changes of life style during the test period.
15) Individuals who may experience symptoms such as itching at the evaluation site due to the onset of seasonal allergic symptoms such as hay fever during the study period. In addition, persons who may be taking anti-allergy medication or nasal drops.
16) Individuals who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns.
17) Individuals who neglect skin care.
18) Have a history of cosmetic procedures or treatments in the evaluation area
19) Individuals with scars or inflammation at the evaluation site, or those who feel that skin irritation affecting the examination occurs at the evaluation site before or after menstruation.
20) Individuals who are or are possibly pregnant, or are lactating.
21) Individuals who participated in other clinical studies in the past 3 months.
22) Individuals judged inappropriate for the study by the principal.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshitaka |
| Middle name | |
| Last name | Minetoki |
Organization
Nikken Foods Co.,Ltd.
Division name
Research and Development Division
Zip code
437-0122
Address
723-1 Haruoka, Fukuroi-shi, Shizuoka 437-0122, JAPAN
TEL
0538-49-0121
minetoki@nikkenfoods.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nikken Foods Co.,Ltd.
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064198
