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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033536
Receipt No. R000038239
Scientific Title The health benefits of continue ingested test food (HBF2018-01): a randomized double-blind, paralled-group, placebo-controlled study
Date of disclosure of the study information 2018/09/07
Last modified on 2020/01/31

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Basic information
Public title The health benefits of continue ingested test food (HBF2018-01): a randomized double-blind, paralled-group, placebo-controlled study
Acronym The health benefits of test food (HBF2018-01)
Scientific Title The health benefits of continue ingested test food (HBF2018-01): a randomized double-blind, paralled-group, placebo-controlled study
Scientific Title:Acronym The health benefits of test food (HBF2018-01)
Region
Japan

Condition
Condition Healthy Japanease adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of test food (HBF2018-01) on risk factors for life-style-related diseases in healthy adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Blood glucose, insulin
Measuring: at 0 and 12 weeks after ingestion
Key secondary outcomes 1.Body physical measurement
2.Blood biochemical examination
3.Blood pressure
4.PAI-1 ,HMW-adiponectctin
2,4 Measuring: at 0 and 12 weeks after ingestion
1,3 Measuring:at 0,4,8 and 12weeks afte ingestion

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 Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test food(HBF2018-01) twice a day(at lunch time and at dinner time) for 12 weeks
Interventions/Control_2 Oral ingestion of the placebo control food twice a day(at lunch time and at dinner time) for 12 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
60 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy Japanease adults
2)Employees at the Hayashibara CO.,LTD.
3)Subjects who signed the informed consent for participation in the study
4)Individuals judged appropriate for the study by the principal investigator
Key exclusion criteria 1)Subjects with medical fistory of sever disorders
2)Pregnant or have possibility to become pregnant during the study or lactating women
3)Subjects who judged as unsuitable for this study by the principal investigator for any reasons
4)Subjects who are being treated with hyperglycemia.
5)Subjects who have been diagnosed with diabetes in the past
6)Subjects who can not comply with the instruction of conducting the test
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Chiyo
Middle name
Last name Yoshizane
Organization Hayashibara CO., LTD.
Division name R&D Division, Development Unit
Zip code 7028006
Address 675-1, Fujisaki, Naka-ku, Okayama
TEL 086-276-3141
Email chiyo.yoshizane@hb.nagase.co.jp

Public contact
Name of contact person
1st name Chiyo
Middle name
Last name Yoshizane
Organization Hayashibara CO., LTD.
Division name R&D Division, Development Unit
Zip code 7028006
Address 675-1, Fujisaki, Naka-ku, Okayama
TEL 086-276-3141
Homepage URL
Email chiyo.yoshizane@hb.nagase.co.jp

Sponsor
Institute Hayashibara CO., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Hayashibara Co., Ltd.
Address 675-1, Fujisaki, Naka-ku, Okayama
Tel 086-276-3141
Email HB96301@hb.nagase.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 株式会社林原(岡山県)/Hayashibara CO.,LTD. (Okayama)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 07 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 06 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 07 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 07 Month 27 Day
Last modified on
2020 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038239

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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