UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the safety of the intake of a test food for constipation tendency adults.
Title of the study (Brief title)	A study for evaluating the safety of the intake of a test food.
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of ingestion of a test food for 4 weeks.
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 Doctor's questions Adverse event Intestinal flora
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	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

Eligibility
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	10

Research contact person
Name of lead principal investigator	Hiroki Takagi
Organization	NIHON SHOKUHIN KAKO CO., LTD.
Division name	RESEARCH INSTITUTE
Address	30 TAJIMA FUJI, SHIZUOKA
TEL	0545-53-5995
Email	hiroki.takagi@nisshoku.co.jp

Public contact
Name of contact person	Shingo Yamamichi
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
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

Sponsor
Institute	TTC Co.,Ltd
Institute
Department

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)

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 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 14 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 25 Day
Last modified on	2018 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034883