UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032995
Receipt No. R000037627
Scientific Title A study to evaluate the safety of test foods for healthy adults.
Date of disclosure of the study information 2018/06/14
Last modified on 2018/09/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study to evaluate the safety of test foods for healthy adults.
Acronym A study to evaluate the safety of test foods.
Scientific Title A study to evaluate the safety of test foods for healthy adults.
Scientific Title:Acronym A study to evaluate the safety of test foods.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of ingestion of test foods for 4 weeks.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical, Hematologic, Blood biochemical, Urinalysis, Doctor' s questions, Weight before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food 175 mg per day for 4 consecutive weeks
Interventions/Control_2 Intake of test food 350 mg per day for 4 consecutive weeks
Interventions/Control_3 Intake of test food 700 mg per day for 4 consecutive weeks
Interventions/Control_4 Intake of test food 1050 mg per day for 4 consecutive weeks
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 Healthy males and females aged 20-64 years old
Key exclusion criteria 1.Subjects who constantly use health food richly containing involvement ingredient
2.Subjects who have serious illness such as diabetes, liver disease, kidney disease, heart disease
3.Subjects who have possibilities for emerging allergy onset related to the study
4.Subjects with chronic illness or medication
5.Subjects with an irregular diet habit
6.Subjects who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements
7.Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
8.Subjects who intend to become pregnant or lactating
9.Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
10.Subjects who are judged as ineligible by clinical investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Sato
Organization Shiratori Pharmaceutical Co., Ltd.
Division name Research and Development Dept
Zip code
Address 6-11-24 Tsudanuma, Narashino-city, Chiba-pref
TEL 047-453-2500
Email y-sato@shiratori-pharm.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotoha Isobe
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 k.isobe@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization Shiratori Pharmaceutical 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 06 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
2018 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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
2018 Year 06 Month 14 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.