UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018528
Receipt number R000021419
Scientific Title Safety evaluation studies of excessive consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects
Date of disclosure of the study information 2015/08/07
Last modified on 2016/05/20 09:29:08

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Basic information

Public title

Safety evaluation studies of excessive consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects

Acronym

Safety evaluation studies of excessive consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects

Scientific Title

Safety evaluation studies of excessive consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects

Scientific Title:Acronym

Safety evaluation studies of excessive consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of food containing resistant glucan (water-soluble dietary fiber), 3-fold quantity of recommended daily intake.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse event

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of the test product for 4 weeks

Interventions/Control_2


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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Healthy adult males and females from 20 to 64 years of age
(2) Subjects falling under any of the following
A. 10 subjects whose normal stool frequency is around 3-5 times per week
B. 10 subjects whose normal stool frequency is around 7 times per week

Key exclusion criteria

(1) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative
(2) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy)
(3) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases
(4) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease
(5) Subjects having possibilities for emerging allergy related to the study
(6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(9) Subjects who intend to become pregnant or lactating
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(11) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiro Yamamoto

Organization

NIHON SHOKUHIN KAKO CO., LTD.

Division name

RESEARCH INSTITUTE

Zip code


Address

30 TAJIMA FUJI, SHIZUOKA

TEL

0545-53-5995

Email

toshihiro.yamamoto@nisshoku.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuki Kitahara

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

y.kitahara@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

NIHON SHOKUHIN KAKO 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

2015 Year 08 Month 07 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

2015 Year 07 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 08 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

2015 Year 08 Month 03 Day

Last modified on

2016 Year 05 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021419


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name