Unique ID issued by UMIN | UMIN000035336 |
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Receipt number | R000040256 |
Scientific Title | A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level. -Randomised double-blind placebo-controlled trial |
Date of disclosure of the study information | 2019/01/11 |
Last modified on | 2019/06/24 11:28:14 |
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level.
-Randomised double-blind placebo-controlled trial
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level.
-Randomised double-blind placebo-controlled trial
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level.
-Randomised double-blind placebo-controlled trial
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level.
-Randomised double-blind placebo-controlled trial
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the efficacy of test food intake on the suppression of the elevation of postprandial blood glucose level after ingesting rice meal.
Efficacy
Time course of blood glucose level and AUC (area under the curve)(0-2hrs).
Time course of blood insulin level and AUC (area under the curve)(0-2hrs).
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Test participants intake one package of test food dissolved in 180ml water 15 min before consuming rice meal.
Test participants intake one package of control food dissolved in 180ml water 15 min before consuming rice meal.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) Males and females aged 20 to 64 years old when informed consent and body mass index (BMI) is included between 18.5 to less than 30
(2)Individuals who fasting blood glucose level at the time of screening is 100 mg/dl or more 125 mg/dl or less, or glucose load test 2 hours after glucose level is 140 mg/dl or more 199 mg/dl or less, individuals who are judged to normal high blood glucose level or borderline diabetes by the principal investigator
(3)Individuals who do not drink large amount of alcohol habitually
(4) Individuals who are judged that not suffering from a disease
(5)Individuals giving written informed consent
(1) Individuals whose fasting blood glucose level at the time of screening is 126mg/dl or more, or glucose level is 200mg/dl or more 2 hours after the glucose load test
(2)Individuals who use oral medication affecting blood glucose level
(3)Individuals who constantly use supplements and/or functional foods, including food for specified health use and/or food with function claims, affecting blood glucose level
(4)Individuals who were judged to be diagnosed with diabetes at the screening checkup
(5)Individuals who are suffering from or under treatment of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder
(6) Individuals who have a chronic disease and use medicines continuously
(7)Individuals who have a history of digestive disease and/or surgical history affecting digestion and absorption , have a disorder such as stenosis in the gastrointestinal tract
(8)Individuals who had an onset diarrhea within one week from the date of screening, and who is prone to diarrhea always
(9)Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(10) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
50
1st name | |
Middle name | |
Last name | Yoshitaka Iwama |
Nihonbashi Cardiology Clinic
Director
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
niho-jimucho@well-sleep.jp
1st name | |
Middle name | |
Last name | Yoshika Komori |
KSO Corporation
Sales department
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshi@kso.co.jp
KSO Corporation
Nissin Foods Holdings Co.,Ltd.
Profit organization
NO
2019 | Year | 01 | Month | 11 | Day |
Unpublished
Completed
2018 | Year | 12 | Month | 07 | Day |
2018 | Year | 12 | Month | 05 | Day |
2019 | Year | 01 | Month | 12 | Day |
2019 | Year | 02 | Month | 09 | Day |
2018 | Year | 12 | Month | 21 | Day |
2019 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040256
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