UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053476 |
|---|---|
| Receipt number | R000060962 |
| Scientific Title | Study of the Effects of Ingestion of the Test Food on Skin Function and Intestinal Environment. |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2025/01/21 17:06:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the Effects of Ingestion of the Test Food on Skin Function and Intestinal Environment.
Acronym
Study of the Effects of Ingestion of the Test Food on Skin Function and Intestinal Environment.
Scientific Title
Study of the Effects of Ingestion of the Test Food on Skin Function and Intestinal Environment.
Scientific Title:Acronym
Study of the Effects of Ingestion of the Test Food on Skin Function and Intestinal Environment.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of ingestion of the test food on skin function and intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes of skin function and intestinal environment.
(Week 0, Week 8)
Key secondary outcomes
*Secondary outcome
1) Observation for skin condition by dermatologists (1)
2) Putrefactive metabolites in blood (1)
3) Fecal organic acid (1)
*Sensory index
1) Visual Analogue Scale (1)
*Eating trend index
1) Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ) (1)
* Safety indexes
1) Blood pressure, pulsation (1)
2) Weight, body fat percentage, BMI (1)
3) Doctor's questions, Side effects and adverse events (1)
4) Subject's diary (2)
(1): Week 0, Week 8
(2): 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 (1 bottle in a day; 8 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 bottle in a day; 8 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 35-59 years at the time of obtaining consent to participate in the study.
2) Individuals who are healthy and have no chronic physical disease including skin disorder.
3) Individuals who are concerned about dry or flaky skin.
4) Individuals whose written informed consent has been obtained.
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 with strange skin conditions at measurement points.
3)Individuals who have wounds or inflammation in the evaluation site.
4)Individuals who used a drug to treat a disease in the past 1 month.
5)Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
6)Individuals who are a patient or have a history of or endocrine disease.
7)Individuals with serious anemia.
8)Individuals whose BMI is over 30 kg/m2.
9)Individuals who are sensitive to test product or other foods, and medical products.
10)Individuals who habitually take the foods for specified health uses (FOSHU) or functional food.
11)Individuals who have a habit to ingest or use health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period.
12)Individuals who excessively take alcohol.
13)Individuals who are patient or have a history of psychiatric disease.
14)Individuals who are a smoker.
15)Individuals who engage in work such as sales or delivery, and who spend long time in outdoor activities and exposure to ultraviolet rays in their daily lives.
16)Individuals who engage in a night work.
17)Individuals with possible changes of lifestyle during the test period.
18)Individuals who will develop seasonal allergy symptoms like hay fever and be to suffer from worsening eyes and nose symptoms or use anti-allergic drugs during the test period.
19)Individuals who neglect skin care.
20)Individuals who will get sunburned during the test period.
21)Individuals who had been conducted an operation or beauty treatment on the evaluation area within 6 months before the start of the test.
22)Individuals who are pregnant, lactating, or who may become pregnant during the test period.
23)Individuals who participated in other clinical studies in the past 3 months.
24)Individuals judged inappropriate for the study by the principal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
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
Matsutani Chemical Industry 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 | 01 | Month | 31 | 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 | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060962
