UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034898
Receipt number R000039784
Scientific Title Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.
Date of disclosure of the study information 2018/11/25
Last modified on 2021/12/13 15:40:21

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Basic information

Public title

Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.

Acronym

Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.

Scientific Title

Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.

Scientific Title:Acronym

Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of flow-mediated dilation ( FMD ) response after intake of heat-moisture treated brown rice flour cracker with those of brown and polished rice flour crackers without heat-moisture treatment in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

FMD value

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants 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

Test food : heat-moisture treated koshiibuki brown rice flour cracker / dose : 60g / eating for 10min

Interventions/Control_2

Placebo food -1 : koshiibuki brown rice flour cracker / dose : 60g / eating for 10min

Interventions/Control_3

Placebo food -2 : polished koshiibuki rice flour cracker / dose : 60g / eating for 10min

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1.Those with a low fasting FMD value.
2.Volunteer having screening test result and questionnaire result judged to be appropriate for this study by investigator.

Key exclusion criteria

1.Diabetes under medical treatment.
2.Volunteers having diseases (e.g. liver, kindney, heart, blood diseases, and infections requiring the notification)
3.Volunteers received gastrectomy, enterectomy, and gastro-intestinal diseases, juded to be inappropriate for this study.
4.Pregnant, women having the possibility, and lactating women.
5.Paticipants in other clinical trial.
6.Volunteers rejected participating in this study by chief investigator.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Watanabe

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Medicine and Clinical Epidemiology for Prevention of Noncommunicable Diseases

Zip code

956-0841

Address

1 Asahimachi-dori, Chuo-ku, Niigata, Japan (951-8510)

TEL

025-368-9026

Email

wataken@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Goto

Organization

Niigata Bio-Research Park, Inc

Division name

Business promotion division

Zip code

956-0841

Address

316-2 Higashijima, Akiha-ku, Niigata, Japan (956-0841)

TEL

0250-25-1196

Homepage URL


Email

goto@nbrp.co.jp


Sponsor or person

Institute

Niigata Bio-Research Park, Inc

Institute

Department

Personal name



Funding Source

Organization

Niigata University Graduate School of Medical and Dental Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata Bio-Research Park, Inc

Address

316-2 Higashijima, Akiha-ku, Niigata, Japan (956-0841)

Tel

0250-25-1196

Email

nbrp-food-navi@nbrp.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



Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 25 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 10 Month 31 Day

Date of IRB

2018 Year 10 Month 22 Day

Anticipated trial start date

2018 Year 11 Month 25 Day

Last follow-up date

2019 Year 02 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 15 Day

Last modified on

2021 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039784


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name