UMIN-CTR Clinical Trial

Public title

Comparison of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized , crossover study

Acronym

Comparison of the efficacy of dietary fiber-containing food on gastrointestinal condition

Scientific Title

Comparison of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized , crossover study

Scientific Title:Acronym

Comparison of the efficacy of dietary fiber-containing food on gastrointestinal condition

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Comparison of the efficacy of the dietary fiber-containing food on gastrointestinal condition

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Defecation frequency

Key secondary outcomes

Defecation days, stool volume, stool shape, stool color, stool smell and the feeling after defecation

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Taking a control food for 14 days -> Washout period for 14 days -> Taking a test food A for 14 days -> Washout period for 14 days -> Taking a test food B for 14 days

Interventions/Control_2

Taking a control food for 14 days -> Washout period for 14 days -> Taking a test food B for 14 days -> Washout period for 14 days -> Taking a test food A for 14 days

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Healthy males and females from 20 to 60 years old
2)Subjects with defecation at three to five times per week
3) Usually eat three meals a day
4)Subjects who have received written informed consent

Key exclusion criteria

1) Subjects who regularly use laxatives
2) Subjects who regularly take foods which may affect gastrointestinal condition at the screening period
3) Subjects who regularly use antibiotics and other medicines which affect digestion and absorption at the screening period and taking control food period
4) Subjects who cannot abstain from taking foods which are containing viable bacteria, enriched with oligosaccharides or dietary fiber, considered effective for constipation improvement and are containing large amount of sugar alcohol
5) Subjects who have allergy for foods
6) Subjects who regularly take too much alcohol(more than 60g/day as a pure alcohol for 5 days or more)
7) Subjects who have diseases which require urgent treatment or severe complications
8)Subjects who have gastrointestinal diseases or a surgical history which may affect digestion, absorption and defecation
9)Subjects who are judged to be inappropriate for the study from the answers to the background questionnaire
10) Subjects who are pregnant, lactating or planning to be pregnant in the test period
11) Subjects who are under treatment or have a history of drug addiction or alcoholism
12) Subjects who are participating or planning to participate in a clinical study
13) Subjects who are judged as inappropriate by investigator

Target sample size

30

Name of lead principal investigator

1st name	Yoshitaka
Middle name
Last name	Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

103-0001

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp

Name of contact person

1st name	Yoshika
Middle name
Last name	Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building

TEL

03-3452-7733

Homepage URL

Email

yoshi@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shinagawa Season Terrace Health Care Clinic

Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

Tel

03-3452-3382

Email

tomohiro_kogo@sempos.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2019

Year

07

Month

30

Day

Date of IRB

2019

Year

08

Month

15

Day

Anticipated trial start date

2019

Year

10

Month

20

Day

Last follow-up date

2019

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

08

Month

30

Day

Last modified on

2020

Year

08

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043141