UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031693
Receipt number R000036196
Scientific Title Evaluation of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized, placebo controlled, crossover study
Date of disclosure of the study information 2018/03/13
Last modified on 2019/03/13 09:42:00

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation 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



Assessment

Primary outcomes

Number and ratio of fecal Bifidobacterium
Defecation frequency

Key secondary outcomes

Defecation days, stool volume, stool shape, stool color, stool smell and the feeling after defecation
Intestinal microflora analysis
Fecal ammonia measurement
Fecal pH measurement
Fecal water content measurement
Stool weight


Base

Study type

Interventional


Study design

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



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Taking a control food for 14 days -> Washout period for 21 days -> Taking a test food at low dose for 14 days -> Washout period for 21 days -> Taking a test food at high dose for 14 days

Interventions/Control_2

Taking a test food at low dose for 14 days -> Washout period for 21 days -> Taking a test food at high dose for 14 days -> Washout period for 21 days -> Taking a control food for 14 days

Interventions/Control_3

Taking a test food at high dose for 14 days -> Washout period for 21 days -> Taking a control food for 14 days -> Washout period for 21 days -> Taking a test food at low dose for 14 days

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1)Healthy males and females from 20 to 64 years old
2)Subjects with defecation at three to five times per week
3)Subjects with fewer number and lower ratio of Bifidobacterium in feces
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
3) Subjects who regularly use antibiotics and other medicines which affect digestion and absorption
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
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 pregnant, lactating or planning to be pregnant in the test period
10) Subjects who are under treatment or have a history of drug addiction or alcoholism
11) Subjects who are participating or planning to participate in a clinical study
12) Subjects who are judged as inappropriate by investigator

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoru Suzuki

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Medical examination and treatment management family chief director

Zip code


Address

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

TEL

03-3452-3381

Email

satoru_suzuki@sempos.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshika Komori

Organization

KSO Corporation

Division name

Sales department

Zip code


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


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



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


Address


Tel


Email



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

2018 Year 03 Month 13 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

2018 Year 02 Month 09 Day

Date of IRB

2018 Year 02 Month 23 Day

Anticipated trial start date

2018 Year 03 Month 13 Day

Last follow-up date

2018 Year 08 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 12 Day

Last modified on

2019 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036196


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name