Unique ID issued by UMIN | UMIN000036242 |
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Receipt number | R000041281 |
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 | 2019/03/18 |
Last modified on | 2020/03/05 18:26:30 |
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
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
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the efficacy of test food intake on the suppression of the elevation of postprandial blood glucose after ingesting glucose.
Efficacy
Blood glucose
*Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.
Insulin
*Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Food containing test food + glucose 75 g, single ingestion [Wash out for 1 week] Food not containing test food + glucose 75 g, single ingestion
Food not containing test food + glucose 75 g, single ingestion [Wash out for 1 week] Food containing test food + glucose 75 g, single ingestion
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1) Males and females, aged 20 - 65 years old.
2) Subjects whose fasting blood glucose level is from 110 mg/dL to 125 mg/dL or two-hour blood glucose level after 75 g glucose loading is from 140 mg/dL to 199 mg/dL, and who are judged normal-high or borderline type as the state of glycemia by the principal investigator.
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
1) Subjects whose fasting blood glucose level is greater than or equal to 126 mg/dL and two-hour blood glucose level after 75 g glucose loading is greater than or equal to 200 mg/dL.
2) A medical history of malignant tumor, heart failure or myocardial infarction.
3) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4) Subjects who currently taking medications (including herbal medicines)
5) Subjects who are allergic to medications and/or the test food related products.
6) Subjects with irregular life rhythms such as shift workers, irregular eating habits.
7) Subjects who are pregnant, breast-feeding, or planning to get pregnant.
8) Subjects who have been enrolled in other clinical trials within the last 4 weeks before the agreement to participate in this trial.
9) Subjects who are considered as ineligible to participate in the study by the physician.
30
1st name | Yasutaka |
Middle name | |
Last name | Makishima |
Allegro Inc.
Clinical trial promotion department
151-0051
4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo
03-5363-6821
y-maki@bml.co.jp
1st name | Fumiko |
Middle name | |
Last name | Kase |
Allegro Inc.
Clinical trial promotion department
151-0051
4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo
03-5363-6821
f-kase@bml.co.jp
Allegro Inc.
Pharma Foods International Co., Ltd.
Profit organization
MC Food Specialties Inc.
Tomisaka Clinic
1-33-9, Hongo, Bunkyo-ku, Tokyo
03-3814-2662
info@tomisaka.or.jp
NO
2019 | Year | 03 | Month | 18 | Day |
Unpublished
Completed
2019 | Year | 02 | Month | 21 | Day |
2019 | Year | 03 | Month | 13 | Day |
2019 | Year | 03 | Month | 18 | Day |
2019 | Year | 05 | Month | 31 | Day |
2019 | Year | 03 | Month | 18 | Day |
2020 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041281
Research Plan | |
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Research case data | |
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