UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017447
Receipt number R000020082
Scientific Title Effects of grain constituent on postprandial hyperglycemia : placebo-controlled double blind cross-over trial
Date of disclosure of the study information 2015/05/16
Last modified on 2019/08/22 11:30:15

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Basic information

Public title

Effects of grain constituent on postprandial hyperglycemia
: placebo-controlled double blind cross-over trial

Acronym

Effects of grain constituent on postprandial hyperglycemia

Scientific Title

Effects of grain constituent on postprandial hyperglycemia
: placebo-controlled double blind cross-over trial

Scientific Title:Acronym

Effects of grain constituent on postprandial hyperglycemia

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of a food product on postprandial hyperglycemia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood samples were collected before ingestion and 0.5,1,2,3,4 and 5 hours after ingestion.Urine samples were collected before ingestion and accumulation urine samples were pooled during the postprandial reriods for 5 hrs. Primary outcome is postprandial blood glucose

Key secondary outcomes

Key secondary outcomes are insulin, triglyceride and glucose-dependent insulinotropic polypeptide.


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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The subjects ingested a single intake of the active meal, and ingested a single intake of the placebo meal after 7 days.

Interventions/Control_2

The subjects ingested a single intake of the placebo meal, and ingested a single intake of the active meal after 7 days.

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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Male

Key inclusion criteria

1) Twenty subjects are divided into two groups at each ten subjects as described bilow.
10 subjects whose fasting blood glucose levels are ranged from 110 mg/dl to less than 125 mg/dl .10 subject whose fasting blood glucose levels are ranged to less than 110 mg/dl.
2) Subjects whose BMI are from 20 kg/m2 to less than 28 kg/m2.
3) Subjects whose systolic blood pressure is 139 mmHg or less and diastolic blood pressure is 89 mmHg or less.
4) Subjects whose triglyceride is 50 mg/dl or more and 149 mg/dl or less.
5) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1) Subjects who take continuous medical treatment.
2) Subjects who are contracting heart disease, liver disease, kidney disease, digestive disease and allergy disease.
3) Subjects with serious infection
4) Subjects with smoking habit
5) Those whose amount of drinking on the 1st is more than 500 ml in beer conversion.
6) Subjects who are doing carbohydrates restricted diet now.
7) Subjects who participate in other clinical trials.
8) Subjects who are not eligible due to physician's judgment.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Chiaki
Middle name
Last name Shibakiri

Organization

QOL RD Co.,Ltd.

Division name

CRO Department Food Division

Zip code

1030027

Address

Front Place Nihonbashi Bldg.,2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027,Japan

TEL

03-6386-8809

Email

c-shibakiri@qol-rd.co.jp


Public contact

Name of contact person

1st name Higashino
Middle name
Last name Nobuyuki

Organization

QOL RD Co.,Ltd.

Division name

CRO Department Food Division

Zip code

1030027

Address

Front Place Nihonbashi Bldg.,2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027,Japan

TEL

03-6386-8809

Homepage URL


Email

n-higashino@qol-rd.co.jp


Sponsor or person

Institute

QOL RD Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Human Research Ethics Committee of Biological Science Laboratories of Kao Corporation

Address

2606, Akabane,Ichikai-Machi,Haga-Gun,Tochigi 321-3497,Japan

Tel

0285-68-7589

Email

taguchi.hiroyuki@kao.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

医療法人社団冠心会大崎病院東京ハートセンター(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 16 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Published


Result

URL related to results and publications

http://pubs.sciepub.com/jfnr/5/5/1/

Number of participants that the trial has enrolled

23

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

Main results already published

Date of protocol fixation

2015 Year 03 Month 18 Day

Date of IRB

2015 Year 02 Month 18 Day

Anticipated trial start date

2015 Year 05 Month 16 Day

Last follow-up date

2018 Year 08 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 07 Day

Last modified on

2019 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020082


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name