UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033536
Receipt number 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 16:32:32

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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 or person

Institute

Hayashibara CO., LTD.

Institute

Department

Personal name



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

Value
https://center6.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