UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018065 |
|---|---|
| Receipt number | R000020794 |
| Scientific Title | GlycemicIndex about the barley |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/06/28 08:40:17 |
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Basic information
Public title
GlycemicIndex about the barley
Acronym
GI about the barley
Scientific Title
GlycemicIndex about the barley
Scientific Title:Acronym
GI about the barley
Region
| Japan |
Condition
Condition
Man and woman (there is not taking drug including the antihypertensive agent without impaired glucose tolerance by a blood test for the past one year) with BMI from 20 years old to 50 years old less than 30 kg/square meter
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The blood sugar level after a meal is controlled so that there are many ratios of wheat, but I think that it is 30% degree for the ratio that it is easy to eat and continues it and can take in and carry out the hospital diet at 30%. In the Japanese eating habits, I often eat the boiled barley and rice with a yam, but am not inspected whether it is that how becomes blood sugar level after a meal. Therefore I decided to study change of the blood sugar level and change of the blood sugar level when I took in GI and boiled barley and rice and side dishes together and GI for physically unimpaired people after a meal when I took in polished rice and boiled barley and rice with a yam. I examined a physically unimpaired person about a change of the blood sugar level after a meal when I consumed boiled barley and rice with grated yam and the natto which were viscous food this time. Furthermore, I study change of the blood sugar level when I took in the side dishes of meat dishes, fish dishes, the egg dish together and GI for physically unimpaired people.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The tendency to restrain a rise in blood sugar was watched in the inspection food that I added boiled barley and rice and natto to only in comparison with polished rice than a blood sugar change and AUC, but I did the significant difference, and a tendency to restrain a rise in blood sugar with polished rice + grated yam in the inspection food that I added grated yam to again after a meal was watched, but there was not significant difference. On the other hand, with the boiled barley and rice + grated yam, I significantly controlled an ascent of blood sugar after a meal. In addition, a tendency to restrain an ascent of blood sugar after a meal by taking it in with barley and viscous food was watched. Furthermore, as for the staple food, a tendency to restrain an ascent of blood sugar after a meal when boiled barley and rice combined it with viscous food than polished rice was watched. The barley content of the boiled barley and rice which I examined this time is 30% and thinks that it is the ratio that it is easy to eat, and is easy to continue. I often ate boiled barley and rice and grated yam as the Japanese eating habits together, and it was suggested to be logical how to eat to control an ascent of blood sugar after a meal.
I want to use the GI level of the food as a tool to maintain the blood sugar control of the diabetic by nourishment meal instruction well effectively.
Key secondary outcomes
This study expressed a change of the blood sugar measurement after each food intake for physically unimpaired people. It is lacking in insulin secretion, and the usefulness for the diabetic is not planned.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
[standard food]
Using Japanese GI meeting for the study protocol, I investigate the blood sugar change at the time of the following food intake. I measure the blood sugar for 120 minutes after the measurement (if it is less than 110, blood sugar can measure it from 70 at the time of hunger), follows food intake with a glucose kit in blood sugar for self-inspection for 90 minutes for 60 minutes for 45 minutes for 30 minutes for 15 minutes of (performing it in 5-10 minutes at intake time, and chewing around 30 times of mouthful) in fasting without consuming breakfast on the inspection day. It is inspection food (I avoid smoking during the measurement, and as work degree of the quiet Sagitta rank who I stand, and work): Polished rice (50.1 g of 149 g of rice Koshihikari (glucide of the sugar food sugar from Niigata))
Interventions/Control_2
[inspection food]
Using Japanese GI meeting for the study protocol, I investigate the blood sugar change at the time of the following food intake. I measure the blood sugar for 120 minutes after the measurement (if it is less than 110, blood sugar can measure it from 70 at the time of hunger), follows food intake with a glucose kit in blood sugar for self-inspection for 90 minutes for 60 minutes for 45 minutes for 30 minutes for 15 minutes of (performing it in 5-10 minutes at intake time, and chewing around 30 times of mouthful) in fasting without consuming breakfast on the inspection day. It is inspection food (I avoid smoking during the measurement, and as work degree of the quiet Sagitta rank who I stand, and work): 176 g of wheat rice (50.0 g of rice wheat rice (glucide of the sugar food sugar))
Interventions/Control_3
[inspection food]
Using Japanese GI meeting for the study protocol, I investigate the blood sugar change at the time of the following food intake. I measure the blood sugar for 120 minutes after the measurement (if it is less than 110, blood sugar can measure it from 70 at the time of hunger), follows food intake with a glucose kit in blood sugar for self-inspection for 90 minutes for 60 minutes for 45 minutes for 30 minutes for 15 minutes of (performing it in 5-10 minutes at intake time, and chewing around 30 times of mouthful) in fasting without consuming breakfast on the inspection day. It is inspection food (I avoid smoking during the measurement, and as work degree of the quiet Sagitta rank who I stand, and work)
1.I break 114 g of polished rice (rice Koshihikari of the sugar food sugar from Niigata), yam grated yam 80 g (seven premium), soup stock and take in 5 ml of soy sauce (Kikkoman). (50.1 g of quantity of total glucide)
2.I break 135 g of wheat rice (rice wheat rice of the sugar food sugar), yam grated yam 80 g (seven premium), soup stock and take in 5 ml of soy sauce (Kikkoman). (50.1 g of quantity of total glucide)
1.And it is decided that the inspection of 2. passes more than one day.
Interventions/Control_4
[inspection food]
Using Japanese GI meeting for the study protocol, I investigate the blood sugar change at the time of the following food intake. I measure the blood sugar for 120 minutes after the measurement (if it is less than 110, blood sugar can measure it from 70 at the time of hunger), follows food intake with a glucose kit in blood sugar for self-inspection for 90 minutes for 60 minutes for 45 minutes for 30 minutes for 15 minutes of (performing it in 5-10 minutes at intake time, and chewing around 30 times of mouthful) in fasting without consuming breakfast on the inspection day. It is inspection food (I avoid smoking during the measurement, and as work degree of the quiet Sagitta rank who I stand, and work)
Inspection food
1.I take in 114 g of polished rice (rice Koshihikari of the sugar food sugar from Niigata), chicken hamburger steak 90 g (Ishii Food). (50.0 g of quantity of total glucide)
2.I take in 135 g of wheat rice (I make out rice wheat of the sugar food sugar), chicken hamburger steak 90 g (Ishii Food). (50.0 g of quantity of total glucide)
1.And it is decided that the inspection of 2. passes more than one day.
Interventions/Control_5
[inspection food]
Using Japanese GI meeting for the study protocol, I investigate the blood sugar change at the time of the following food intake. I measure the blood sugar for 120 minutes after the measurement (if it is less than 110, blood sugar can measure it from 70 at the time of hunger), follows food intake with a glucose kit in blood sugar for self-inspection for 90 minutes for 60 minutes for 45 minutes for 30 minutes for 15 minutes of (performing it in 5-10 minutes at intake time, and chewing around 30 times of mouthful) in fasting without consuming breakfast on the inspection day. It is inspection food (I avoid smoking during the measurement, and as work degree of the quiet Sagitta rank who I stand, and work)
Inspection food
1.149 g of polished rice (I take in rice Koshihikari of the sugar food sugar from Niigata, 1, Shioyaki sharpness (seven premium) of the mackerel.) (50.1 g of quantity of total glucide)
2.176 g of wheat rice (I take in rice wheat rice of the sugar food sugar, 1, Shioyaki sharpness (seven premium) of the mackerel.) (50.0 g of quantity of total glucide)
1.And it is decided that the inspection of 2. passes more than one day.
Interventions/Control_6
[inspection food]
Using Japanese GI meeting for the study protocol, I investigate the blood sugar change at the time of the following food intake. I measure the blood sugar for 120 minutes after the measurement (if it is less than 110, blood sugar can measure it from 70 at the time of hunger), follows food intake with a glucose kit in blood sugar for self-inspection for 90 minutes for 60 minutes for 45 minutes for 30 minutes for 15 minutes of (performing it in 5-10 minutes at intake time, and chewing around 30 times of mouthful) in fasting without consuming breakfast on the inspection day. It is inspection food (I avoid smoking during the measurement, and as work degree of the quiet Sagitta rank who I stand, and work)
Inspection food
1.I take in 149 g of polished rice (rice Koshihikari of the sugar food sugar from Niigata), hot spring egg one (seven premium). (50.1 g of quantity of total glucide)
2.176 g of wheat rice (I take in rice wheat rice of the sugar food sugar, one hot spring egg (seven premium).) (50.0 g of quantity of total glucide)
1.And it is decided that the inspection of 2. passes more than one day.
Interventions/Control_7
[inspection food]
Using Japanese GI meeting for the study protocol, I investigate the blood sugar change at the time of the following food intake. I measure the blood sugar for 120 minutes after the measurement (if it is less than 110, blood sugar can measure it from 70 at the time of hunger), follows food intake with a glucose kit in blood sugar for self-inspection for 90 minutes for 60 minutes for 45 minutes for 30 minutes for 15 minutes of (performing it in 5-10 minutes at intake time, and chewing around 30 times of mouthful) in fasting without consuming breakfast on the inspection day. It is inspection food (I avoid smoking during the measurement, and as work degree of the quiet Sagitta rank who I stand, and work)
Inspection food
1.I break 140 g of polished rice (rice Koshihikari of the sugar food sugar from Niigata), very small grain natto 45 g (seven premium), soup stock and take in 5 ml of soy sauce (Kikkoman). (50.0 g of quantity of total glucide)
2.166 g of wheat rice (I break rice wheat rice of the sugar food sugar, 45 g of very small grain natto (seven premiums), soup stock and take in 5 ml of soy sauce (Kikkoman).) (50.1 g of quantity of total glucide)
1.And it is decided that the inspection of 2. passes more than one day.
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
Man and woman (there is not taking drug including the antihypertensive agent without impaired glucose tolerance by a blood test for the past one year) with BMI from 20 years old to 50 years old less than 30 kg/square meter
Key exclusion criteria
Under 20 years old
51 years old or older
There is a glucose tolerance geek by a blood test for the past one year.
There is taking drug including the antihypertensive agent.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hironobu hama |
Organization
TheJikeiUniversity School of Medicine
Division name
Department of Nutrition
Zip code
Address
3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
03-5400-1200-5350
hiro_hama@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | atsumi ogawa |
Organization
TheJikeiUniversity School of Medicine
Division name
Department of Nutrition
Zip code
Address
3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
03-5400-1200-5361
Homepage URL
a_ogawa@jikei.ac.jp
Sponsor or person
Institute
TheJikeiUniversity School of Medicine
Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
TheJikeiUniversity School of Medicine
Department of Nutrition
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
東京慈恵会医科大学附属病院（東京都）
東京慈恵会医科大学附属第三病院（東京都）
東京慈恵会医科大学附属柏病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | 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
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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 24 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020794
