UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036443
Receipt number R000041378
Scientific Title Effects of fermented okara consumption at breakfast on diurnal blood glucose responses
Date of disclosure of the study information 2019/04/15
Last modified on 2022/10/10 17:15:24

* 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

Effects of fermented okara consumption at breakfast on diurnal blood glucose responses

Acronym

Effects of fermented okara consumption at breakfast on diurnal blood glucose responses

Scientific Title

Effects of fermented okara consumption at breakfast on diurnal blood glucose responses

Scientific Title:Acronym

Effects of fermented okara consumption at breakfast on diurnal blood glucose responses

Region

Japan Asia(except Japan)


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the present study is to examine the effects of fermented okara consumption at breakfast on diurnal blood glucose responses.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood glucose concentration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Acute ingestion of placebo

Interventions/Control_2

Acute ingestion of unfermented okara

Interventions/Control_3

Acute ingestion of fermented okara

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

21 years-old <=

Age-upper limit

79 years-old >=

Gender

Male

Key inclusion criteria

21 years-old <=, 80 years-old >
Obtained written informed consent from the participant before participation

Key exclusion criteria

1) Diagnosed with diabetes and dyslipidemia by a doctor and on medication or supplementation that influence metabolism
2) Those who are an anti-depressant, insomnia medication and steroid are excluded. Those suffering from sleep apnea syndrome and obese (BMI>35kg/m2) are also excluded
3) Smoker
4) Those who have pacemaker or any other metal implant internally / externally (except silver teeth implant)
5) Those who perform shift work/ travel 2 weeks before intervention

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Shigenobu
Middle name
Last name Shibata

Organization

Waseda University

Division name

Faculty of Science and Engineering

Zip code

162-8480

Address

2-2 Wakamatsu-cho, Shinjuku

TEL

03-5369-7318

Email

shibatas@waseda.jp


Public contact

Name of contact person

1st name Masaki
Middle name
Last name Takahashi

Organization

Tokyo Institute of Technology

Division name

Institute for Liberal Arts

Zip code

152-8550

Address

2-12-1, Ookayama Meguro-ku, Tokyo

TEL

+81-3-5734-2904

Homepage URL


Email

takahashi.m.bp@m.titech.ac.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Procedures concerning Research with Human Subjects, Waseda University

Address

1-104, Totsukamachi, Shinjuku-ku, Tokyo, 169-8050, JAPAN

Tel

03-5272-1639

Email

rinri@list.waseda.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



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 15 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

No longer recruiting

Date of protocol fixation

2019 Year 03 Month 27 Day

Date of IRB

2019 Year 04 Month 17 Day

Anticipated trial start date

2019 Year 04 Month 15 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 08 Day

Last modified on

2022 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name