Unique ID issued by UMIN | UMIN000037449 |
---|---|
Receipt number | R000042633 |
Scientific Title | Examination of the efficacy of single dose high gamma-PGA natto on the suppression of postprandial glucose elevation. -A randomized crossover confirmatory trial- |
Date of disclosure of the study information | 2019/08/02 |
Last modified on | 2020/07/22 09:25:20 |
Examination of the efficacy of single dose high gamma-PGA natto on the suppression of postprandial glucose elevation. -A randomized crossover confirmatory trial-
The single-dose confirmatory trial of the high gamma-PGA natto
Examination of the efficacy of single dose high gamma-PGA natto on the suppression of postprandial glucose elevation. -A randomized crossover confirmatory trial-
The single-dose confirmatory trial of the high gamma-PGA natto
Japan |
Healthy subjects
Not applicable | Adult |
Others
NO
To examine the efficacy of high gamma-PGA natto on the suppression of postprandial glucose elevation
Efficacy
Confirmatory
Explanatory
Not applicable
Incremental area under the curve of plasma glucose (0-30 min)
1.Incremental area under the curve of plasma glucose (0-15, 0-45, 0-60, 0-90, 0-120 min)
2.The level and change from baselaine of plasma glucose (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min)
3.The level and change from baseline of plasma insulin (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min)
4.Organoleptic evaluation (eating quality of test meal)
Interventional
Cross-over
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
NO
Central registration
2
Treatment
Food |
Low gamma-PGA natto
High gamma-PGA natto
20 | years-old | <= |
70 | years-old | >= |
Male and Female
[At the primary registration]
1. Men and postmenopausal women aged 20-70 years old.
2. BMI not less than 18.5 kg/m2, under 25.0 kg/m2.
3. FPG less than 126 mg/dL and HbA1c less than 6.5%.
4. Subjects who can maintain an everyday lifestyle during study period constantly
5. Capable of giving informed consent.
[At the secondary registration]
Subjects who meet the following conditions after the meal loading test with 150g of white rice, that performed after primary registration.
1. The levels of casual plasma glucose less than 200 mg/dL.
2. Priority is given to those with a plasma glucose levels more than 140 mg/dL at post-30 min or at any point of time.
[At the primary registration]
1. Subjects who are treated for diabetes.
2. Subjects who are taking medications for dislipidemia hypertention, and anemia.
3. Subjects who are taking warfarin.
4. Subjects who are habitually taking medication and/or supplement (including "food for specified health use", and "foods with function claims") that affect glucose metabolism.
5.Subjects who are diagnosed for anemia or have treatment history for anemia.
6. Subjects who are difficult to collect blood in health checkup and so on oftenly.
7. Subjects who are enrollment in another interventional study.
8. Subjects who have suspected food allergy to test meal
9. Subjects who were recognized unsuitable for this study by the Investigator.
[At the secondary registration]
1. Subjects who are confirmed to be difficult to collect blood during continuous blood collection using indwelling needle
2. Subjects who were recognized unsuitable for this study by the Investigator.
36
1st name | Koichi |
Middle name | |
Last name | Hashimoto |
University of Tsukuba, Faculty of Medicene
Clinical and translatnal methodology
3050005
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
029-853-3064
koichi.hashimoto@md.tsukuba.ac.jp
1st name | Koichi |
Middle name | |
Last name | Hashimoto |
University of Tsukuba, Faculty of Medicene
Clinical and translatnal methodology
3050005
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
029-853-3064
koichi.hashimoto@md.tsukuba.ac.jp
Clinical and translatnal methodology,
Fuculty of Medicine,
University of Tsukuba
Ministry of Agriculture, Forestry and Fisheries
Japanese Governmental office
1. Takanofoods Co., Ltd.
2. Industrial technology innovation center of Ibaraki prefecture.
3. National agriculture and food research organization, food research institute.
Clinical Research Ethics Committee of University of Tsukuba Hospital
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
029-853-3914
chiken@un.tsukuba.ac.jp
NO
2019 | Year | 08 | Month | 02 | Day |
Unpublished
Preinitiation
2019 | Year | 07 | Month | 17 | Day |
2019 | Year | 07 | Month | 24 | Day |
2019 | Year | 08 | Month | 02 | Day |
2019 | Year | 11 | Month | 27 | Day |
2020 | Year | 01 | Month | 10 | Day |
2020 | Year | 01 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2019 | Year | 07 | Month | 22 | Day |
2020 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042633