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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017447
Receipt No. 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

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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
Institute QOL RD Co.,Ltd.
Institute
Department

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
URL(English) https://upload.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


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