UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025944
Receipt number R000029828
Scientific Title A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency
Date of disclosure of the study information 2017/02/05
Last modified on 2020/10/05 18:20:48

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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 or person

Institute

CPCC Company Limited

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029828


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name