UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Test Food for Defecation Improvement.
Acronym	Effects of a Test Food for Defecation Improvement.
Scientific Title	Effects of a Test Food for Defecation Improvement.
Scientific Title:Acronym	Effects of a Test Food for Defecation Improvement.
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate effects of a test food for defecation improvement and its safety(a randomized, double-blind, placebo-controlled, parallel-group study).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes for evaluating defecation (The Japanese Version of the Constipation Assessment Scale (1), Patient Assessment of Constipation of Quality Of Life scale (1), Bristol stool scale (1), bowel diary (2)). (1):Screening, Week 0, Week 2, Week 4. (2):From the first day of ingestion of a test material to the last day of the test.
Key secondary outcomes	*Safety [1]Blood pressure, pulsation (Screening, Week 0, Week 4). [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4). [3]Doctor's questions (Screening, Week 0, Week 4). [4]Subject's diary (each day during the test period).

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	Food
Interventions/Control_1	Oral intake of the test product (4 capsules in a day for 4 weeks)
Interventions/Control_2	Oral intake of the placebo product (4 capsules in a day for 4 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	60 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Healthy Japanese males and females aged 20-59 years. [2]Individuals who are healthy and have no chronic physical disease. [3]Individuals with a tendency for constipation (at 3-5 times of defecation per week); whose stool shape is relatively hard and who have unpleasant sensation on defecation. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination on a designated check day. [6]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 whose stool frequency is less than 3 times per week. [4]Individuals who are constipated because of intaking internal medicine. [5]Individuals who have idiopathic constipation. [6]Individuals whose eating habits are irregular. [7]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 30. [11]Individuals who are sensitive to a test product or other foods, and medical products. [12]Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements. [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [14]Individuals with possible changes of life style, such as working a night shift, during the test period. [15]Individuals who are or are possibly, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are or whose family is engaged in functional foods or cosmetics. [18]Individuals judged inappropriate for the study by the principal.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Toshifumi Middle name Last name Okusa
Organization	Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Division name	Head of Center
Zip code	110-0005
Address	1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN
TEL	+81-3-5816-0711
Email	info@tes-h.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	+81-3-601-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Kobayashi Pharmaceutical 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
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	2019 Year 03 Month 28 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	60
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	2019 Year 01 Month 29 Day
Date of IRB	2019 Year 01 Month 16 Day
Anticipated trial start date	2019 Year 03 Month 04 Day
Last follow-up date	2019 Year 04 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 28 Day
Last modified on	2019 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040684