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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030556
Receipt No. R000034883
Scientific Title A study for evaluating the safety of the intake of a test food for constipation tendency adults.
Date of disclosure of the study information 2018/01/14
Last modified on 2018/05/22

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Basic information
Public title A study for evaluating the safety of the intake of a test food for constipation tendency 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 constipation tendency adults.
Scientific Title:Acronym 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
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

Public contact
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

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)

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 01 Month 14 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
2017 Year 12 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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