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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023860
Receipt No. R000027488
Scientific Title Effects of rice with barley and tororo on the Glycemic index (GI) and blood concentrations of insulin and glucagon after consuming the meals
Date of disclosure of the study information 2016/09/05
Last modified on 2018/05/16

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Basic information
Public title Effects of rice with barley and tororo on the Glycemic index (GI) and blood concentrations of insulin and glucagon after consuming the meals
Acronym Effects of rice with barley and tororo on GI and blood concentrations of insulin and glucagon
Scientific Title Effects of rice with barley and tororo on the Glycemic index (GI) and blood concentrations of insulin and glucagon after consuming the meals
Scientific Title:Acronym Effects of rice with barley and tororo on GI and blood concentrations of insulin and glucagon
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this trial, we explore the evaluation of rice with barley and tororo, by examining the Glycemic Index (GI) of rice, rice with barley, rice with tororo, and rice with barley and tororo, and by measuring blood concentrations of insulin and glucagon after consuming the meals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood glucose concentration
Key secondary outcomes Blood insulin concentration
Blood glucagon concentration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The subjects consume rice (50g carbohydrate amount). The blood concentrations of glucose, insulin and glucagon are measured just before and 15-120 min after consuming the meal. We determine two-three times.
Interventions/Control_2 The subjects consume rice with barley (50g carbohydrate amount). The blood concentrations of glucose, insulin and glucagon are measured just before and 15-120 min after consuming the meal. We determine one time.
Interventions/Control_3 The subjects consume rice with tororo (50g carbohydrate amount). The blood concentrations of glucose, insulin and glucagon are measured just before and 15-120 min after consuming the meal. We determine one time.
Interventions/Control_4 The subjects consume rice with barley and tororo (50g carbohydrate amount). The blood concentrations of glucose, insulin and glucagon are measured just before and 15-120 min after consuming the meal. We determine one time.
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
50 years-old >
Gender Male and Female
Key inclusion criteria Healthy subjects met criteria as follows
(1) Students and employees at the University of Yanamashi and employees at Hakubaku. Co., Ltd.
(2) Age 20 or over and below the age of 50
(3) Below the BMI of 25
Key exclusion criteria Exclusion criteria is as follows:
(1) Subjects diagnosed as metabolic diseases such as diabetes, hypertension, hyperlipidemia and hyperuricemia
(2) Subjects diagnosed as impaired glucose tolerance in the past year
(3) Subjects with severe infective diseases, with severe diseases such as cancer, with severe external injuries, or/and just before and just after operations.
(4) Subjects consuming anti-diabetic drugs out of National Health Insurance
(5) Subjects consuming routinely health foods such as supplements, which speculatively affect the results of the trial
(6) Smokers
(7) Subjects with excessive alcohol drinking
(8) Subjects with hypersensitiveness for test foods such as barley, wheat, tororo and/or rice (e.g. alimentary allergies) in the trial
(9) Subjects with pregnancy or possibility of pregnancy
(10) Subjects found offensive by doctors, health nurse and persons responsible to the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Mochizuki
Organization University of Yamanashi
Division name The Faculty of Life and Environmental Sciences
Zip code
Address 4-4-37, Takeda, Kofu-shi, Yamanashi
TEL 055-220-8829
Email mochizukik@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Mochizuki
Organization University of Yamanashi
Division name The Faculty of Life and Environmental Sciences
Zip code
Address 4-4-37, Takeda, Kofu-shi, Yamanashi
TEL 055-220-8829
Homepage URL
Email mochizukik@yamanashi.ac.jp

Sponsor
Institute The Faculty of Life and Environmental Sciences, University of Yamanashi
Institute
Department

Funding Source
Organization The Faculty of Life and Environmental Sciences, University of Yamanashi
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hakubaku. Co., Ltd.
University of Shizuoka
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 山梨大学(山梨県)【University of Yamanashi (Yamanashi prefecture)】

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The change in postprandial blood glucose was significantly reduced in the barley group at 15, 30, 60 and 120 minutes and in the barley with yam group at 15 and 90 minutes (p <0.05). There was no significant difference in white rice with yam. A significant decrease in iAUC was observed in barley group and barley with yam group (p <0.05). In addition, the change in insulin was significantly reduced at barley with yam group at 30 and 120 minutes (p <0.05).
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
2016 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 05 Day
Last follow-up date
2017 Year 01 Month 30 Day
Date of closure to data entry
2017 Year 02 Month 28 Day
Date trial data considered complete
2017 Year 02 Month 28 Day
Date analysis concluded
2017 Year 11 Month 20 Day

Other
Other related information the 72nd Annual Meeting of Japan Society of Nutrition and Food Science

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2018 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027488

Research Plan
Registered date File name
2018/05/16 第72回日本栄養・食糧学会大会要旨集_p212_2I-11p.pdf

Research case data specifications
Registered date File name
2018/05/16 図表一覧.xls

Research case data
Registered date File name


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