UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046845 |
|---|---|
| Receipt number | R000053412 |
| Scientific Title | Effects of a Test Food for the Intestinal Function and the Skin Function, and Its Safety. |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2022/11/04 15:49:10 |
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Basic information
Public title
Effects of a Test Food for the Intestinal Function and the Skin Function, and Its Safety.
Acronym
Effects of a Test Food for the Intestinal Function and the Skin Function, and Its Safety.
Scientific Title
Effects of a Test Food for the Intestinal Function and the Skin Function, and Its Safety.
Scientific Title:Acronym
Effects of a Test Food for the Intestinal Function and the Skin Function, and Its Safety.
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 effects of a test food for the intestinal and the skin function and Its Safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel diary (stool frequency and number of defecation days : Everyday From the seven days before the first day of ingestion of a test material to the last day of the test.)
Key secondary outcomes
*Secondary indexes
[1] Indexes for evaluating defecation
(1)Bowel diary (Volume of defecation, fecal odor, feeling of incomplete defecation: Everyday From the seven days before the first day of ingestion of a test material to the last day of the test.)
(2)The Japanese Version of the Constipation Assessment Scale [middle term] (Week 0, home survey, Week 8)
(3)Bristol stool scale. (Week 0, home survey, Week 8)
(4)Analysis of intestinal flora (Week 0, Week 8)
[2] Index for Skin quality evaluation. (Week 0, Week 8)
[3] Questionnaire of physical feeling. (Week 0, home survey, Week 8)
[4] brief-type self-administered diet history questionnaire. (Week 0, home survey, Week 8)
*Safety
[1] Blood pressure, pulsation. (Week 0, Week 8)
[2] Weight,body fat percentage,BMI. (Week 0, Week 8)
[3] Hematologic test. (Week 0, Week 8)
[4] Blood biochemical test. (Week 0, Week 8)
[5] Urine analysis. (Week 0, Week 8)
[6] Doctor's questions. (Week 0, Week 8)
[7] Side effects/ Adverse events. (Week 0, Week 8)
[8] Subject's diary. (Everyday From the seven days before 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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral intake of the test product (1 pack a day; 8 weeks).
Interventions/Control_2
Oral intake of the placebo product (1 pack 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.
[2] Individuals who are healthy and have no chronic physical disease including skin disease.
[3] Individuals with a tendency for constipation (at 3-4 times of defecation per week); whose stool shape is relatively hard and who have unpleasant sensation on defecation.
[4]Individuals who are aware of skin dryness.
[5] Individuals whose written informed consent has been obtained after explanation of this study.
[6] Individuals who can have an examination on a designated check day
[7] Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals using medical products.
[2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[4] Individuals who are a patient or have a history of or endocrine disease.
[5] Individuals whose stool frequency is less than 3 times per week.
[6] Individuals who are constipated because of intaking internal medicine.
[7] Individuals who have idiopathic constipation.
[8] Individuals whose eating habits are irregular.
[9] Individuals with strange skin conditions at measurement points.
[10] Individuals with strange skin conditions at measurement points.
[11] Individuals who used a drug to treat a disease in the past 1 month.
[12] Individuals with serious anemia.
[13] Individuals whose BMI is over 30 kg/m2.
[14] Individuals who are sensitive to test product or other foods, and medical products.
[15] Individuals who have a habit to ingest special health food, food with functional claims, health-promoting foods, or supplements claiming to improve skin condition and stool in the past 3 months or will ingest those foods during the test period.
[16] Individuals who are or are possibly pregnant, or are lactating.
[17] Individuals who excessively take alcohol.
[18]Individuals who are a smoker.
[19] Individuals with possible changes of life style during the test period.
[20] 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.
[21]individuals who neglect skin care.
[22]Individuals who will get sunburned during the test period.
[23]Individuals who had been conducted an operation or beauty treatment on the test spot.
[24]Individuals who participated in other clinical studies in the past 3 months.
[25]Individuals judged inappropriate for the study by the principal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
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.clinc
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
Toyo Rice Corp.
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
i.takahashi@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
| 2022 | Year | 02 | Month | 14 | 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
| 2022 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 27 | 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 | 02 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053412
