UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency
Acronym	Verification of influence on defecation by consumption of the polydextrose-containing food
Scientific Title	A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency
Scientific Title:Acronym	Verification of influence on defecation by consumption of the polydextrose-containing food
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Confirm the effect on defecation by ingesting the polydextrose containing food for males and females with subjective symptoms of constipation tendency.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of defecation (days of defecation)
Key secondary outcomes	*Feces property (amount, shape, color, smell, sensation after defecation) *Intestinal microflora *Physicochemical analysis of feces ( fecal organic acid, fecal decay products)

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	Intake 2 packs of test food in a day at any time for 2 weeks. Keep interval minimum 6 hrs between test foods intake.
Interventions/Control_2	Intake 2 packs of control food in a day at any time for 2 weeks. Keep interval minimum 6 hrs between control foods intake.
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and females aged 20 to 59 years old. (2) Subjects who defecate 2 to 4 times in a week. (3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	(1)Subjects who are diagnosed as a strong constipation by a doctor. (2)Subjects who are diagnosed with diabetes (including boundary type) by a doctor. (3)Subjects who regularly use medical drugs and/or supplements that have bowel movement improving effect. (4)Pregnant or expected pregnant women, or lactating women. (5)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney and/or digestive trucks. (6)Subjects who excessive alcohol intake. (7)Subjects who have extremely irregular life rhythm, and subjects who have midnight work or irregular shift work. (8)Subjects who have previous medical history of drug and/or food allergy. (9)Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within 4-weeks prior to the current study. Subjects who are planning to participate in other clinical tests of medicines or foods after agreeing with participating in this study. (10)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11)Males who donated over 400mL blood within the last three month to the current study. (12) Females who donated over 400mL blood within the last four month to the current study. (13) Males who will be collected over 1200mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14) Females who will be collected over 800mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (15)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Katsuhisa Middle name Last name Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Sales & Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2017 Year 02 Month 05 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	2017 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 01 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029828