UMIN-CTR Clinical Trial

Public title

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

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 for healthy adults.

Scientific Title:Acronym

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

Region

Japan

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety of excessive (19.5 g ; three times the estimated amount of daily intake) ingestion of a test food for 4 weeks.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight
Doctor's questions
Adverse event
Stool output, defecation frequency, defecation days, fecal condition

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of a test food 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Healthy males and females aged 20-64 years.
(2) Subjects with a tendency for constipation at around three to five times of defecation per week.

Key exclusion criteria

(1) Subjects who routinely use food rich in dietary fiber.
(2) Subjects routinely taking medicine or health food which may influence bowel movement.
(3) Subjects having a large amount of foods which may influence bowel movement such as food containing dietary fiber and lactic acid bacteria.
(4) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative.
(5) Subjects having diseases or a history of drug addiction or alcoholism.
(6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease).
(7) Subjects having possibilities for emerging allergy related to the study.
(8) Subjects who are under medication or having a history of serious diseases for which medication was required.
(9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(10) 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.
(11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(13) Subjects judged as unsuitable for the study by the investigator for other reasons.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Hiroki Takagi

Organization

NIHON SHOKUHIN KAKO CO., LTD.

Division name

RESEARCH INSTITUTE

Zip code

Address

30 TAJIMA FUJI, SHIZUOKA

TEL

0545-53-5995

Email

hiroki.takagi@nisshoku.co.jp

Name of contact person

1st name
Middle name
Last name	Shingo Yamamichi

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

s.yamamichi@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd

Institute

Department

Personal name

Organization

NIHON SHOKUHIN KAKO CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2018

Year

05

Month

28

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

2018

Year

05

Month

10

Day

Date of IRB

Anticipated trial start date

2018

Year

05

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

05

Month

22

Day

Last modified on

2018

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037254