UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000045361
Receipt number R000051797
Scientific Title A study for evaluating the safety of the intake of a test food.
Date of disclosure of the study information 2022/12/21
Last modified on 2023/01/17 17:24:41

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Basic information

Public title

A study for evaluating the safety of the intake of a test food.

Acronym

A study for evaluating the safety of the intake of a test food.

Scientific Title

A study for evaluating the safety of the intake of a test food.

Scientific Title:Acronym

A study for evaluating the safety of the intake of a test food.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The bowel movements and safety of test food after 4 consecutive weeks of ingestion will be examined using placebo as a control.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/body mass index
Bowel movement status (frequency of bowel movements, number of days of bowel movements, volume of bowel movements, stool characteristics)
Adverse event
Evaluate at points of 2 week and 4 week of intake and 2 weeks after the end of ingestion period

Key secondary outcomes



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

Take one bag of the test food once a day for 4 weeks.

Interventions/Control_2

Take one bag of the placebo once a day for 4 weeks.

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) Men and women between 20 and 64 years of age.
(2) Healthy persons who defecated 6 or more times per week during the previous observation period and had diarrhea or soft stools (Bristol stool scale 6 or 7) less than once per week (24 persons)
(3) Persons prone to constipation who defecated 3-5 times a week in the previous observation period and had diarrhea or soft stools (Bristol stool scale 6 and 7) less than once a week (12 persons)
(4) Those who defecated more than 3 times a week and had diarrhea or soft stool (Bristol stool scale 6 or 7) more than once a week in the previous observation period (12 persons)

Key exclusion criteria

(1) Those who regularly use foods (including foods for specified health uses) that contain a lot of dietary fiber materials (indigestible dextrin, polydextrose, indigestible glucan, etc.)
(2) Those who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect bowel movements.
(3) Those who are in the habit of consuming a large amount of foods that are thought to affect bowel movements (foods rich in dietary fiber and lactic acid bacteria)
(4) Persons who are visiting a hospital and using medication for a bowel movement-related disease or who are regularly using over-the-counter laxatives at the time of research participation.
(5) Those with a history or current condition of drug or alcohol dependence.
(6) Persons with serious diseases such as diabetes, liver disease, renal disease, cardiac disease, or those with pre-existing diseases.
(7) Persons at risk of developing allergies related to the research.
(8) Those with a disease under treatment or with a history of serious disease that required medication.
(9) Persons whose anthropometric, physical, and clinical values are significantly out of the reference range before the start of intake.
(10) Those who have participated in other clinical research within one month prior to obtaining consent to participate in this study, or those who plan to participate in other clinical research after obtaining consent to participate in this.
(11) Those who are pregnant or plan to become pregnant or breastfeed during the study period.
(12) Those who are judged to be unsuitable as subjects based on the answers to the lifestyle questionnaire.
(13) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Takagi

Organization

NIHON SHOKUHIN KAKO CO., LTD.

Division name

RESEARCH INSTITUTE

Zip code

417-8530

Address

30 TAJIMA FUJI, SHIZUOKA

TEL

0545-53-5995

Email

hiroki.takagi@nisshoku.co.jp


Public contact

Name of contact person

1st name Shingo
Middle name
Last name Yamamichi

Organization

EP Mediate Co., Ltd.

Division name

Development Business Headquarters, TTC Center, Trial Planning Department

Zip code

162-0822

Address

Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo

TEL

090-4821-1099

Homepage URL


Email

yamamichi.shingo578@eps.co.jp


Sponsor or person

Institute

EP Mediate 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

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

saito.teruo876@eps.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

2022 Year 12 Month 21 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

2021 Year 07 Month 29 Day

Date of IRB

2021 Year 07 Month 29 Day

Anticipated trial start date

2021 Year 09 Month 15 Day

Last follow-up date

2021 Year 12 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 03 Day

Last modified on

2023 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051797


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name