UMIN-CTR Clinical Trial

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