Unique ID issued by UMIN | UMIN000043321 |
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Receipt number | R000049458 |
Scientific Title | A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level: Randomized double-blind placebo-controlled trial |
Date of disclosure of the study information | 2021/02/15 |
Last modified on | 2022/06/30 13:45:24 |
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
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level: Randomized 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 meal.
Safety,Efficacy
- Blood glucose
*Measure at before ingestion and 15, 30, 45, 60, 90, and 120 minutes after ingestion.
- Area Under the Curve
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
1)Test food + rice 200 g, single ingestion
2)Wash out for 1 week
3)Placebo food + rice 200 g, single ingestion
1)Placebo food + rice 200 g, single ingestion
2)Wash out for 1 week
3)Test food + rice 200 g, single ingestion
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Japanese male and female aged 20-64 years old at the time of the informed consent
2) Subjects whose fasting blood glucose level is less than 126 mg/dL or two-hour blood glucose level after 75 g glucose loading is less than 200 mg/dL at the screening test.
3) Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
1)Subject who is considered as a diabetes by a doctor.
2)Subject who is taking medication or under medical treatment.
3)Subject who is under exercise therapy or dietetic therapy.
4)Subject who has an allergy for test food.
5)Subject who has or had a history of either medicine or alcohol dependence syndrome.
6)Subject who has or had a history of mental illness(depression) or sleep disturbance.
7)Subject who is on a night-shift or is a shift worker.
8)Subject whose lifestyle is extremely irregular.
9)Subject who has an unbalanced diet.
10)Subject who is current disease or history of brain disorder, cancer, immunity disorder, diabetes, liver disease(hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases.
11)Subject who is use health foods, supplements, and medicines that may affect diabetes.
12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
13)Subject who has blood drawn 200 mL within the past 1 months or 400 mL within the past 3 months from the day of the consent acquisition.
14)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
15)Subject who can't keep the daily records.
16)Subject who is judged as an inappropriate candidate according to the screening data.
17)Subject who is considered as an inappropriate candidate by the doctor in charge.
30
1st name | Atsushi |
Middle name | |
Last name | Yamatsu |
Pharma Foods International Co., Ltd.
Research and Development
615-8245
1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
075-748-9829
a-yamatsu@pharmafoods.co.jp
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
HUMA R&D CORP
Clinical Development Division
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
ochitani@huma-rd.co.jp
Pharma Foods International Co., Ltd.
Mitsubishi Corporation Life Sciences Limited
Profit organization
the ethics committees of Yoga Allergy Clinic
4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
03-5491-4478
jim@medipharma.co.jp
YES
FH19-001
HUMA R&D CORP
とうきょうスカイツリー駅前内科
2021 | Year | 02 | Month | 15 | Day |
Unpublished
30
Delay expected |
delay of data analysis
Completed
2021 | Year | 01 | Month | 29 | Day |
2021 | Year | 02 | Month | 12 | Day |
2021 | Year | 02 | Month | 15 | Day |
2021 | Year | 07 | Month | 31 | Day |
2021 | Year | 02 | Month | 14 | Day |
2022 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049458
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