UMIN-CTR Clinical Trial

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
Email	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
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053412