UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023860 |
|---|---|
| Receipt number | 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 14:01:15 |
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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
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
mochizukik@yamanashi.ac.jp
Sponsor or person
Institute
The Faculty of Life and Environmental Sciences, University of Yamanashi
Institute
Department
Personal name
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
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
Value
https://center6.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 |
