Unique ID issued by UMIN | UMIN000039508 |
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Receipt number | R000045057 |
Scientific Title | A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level. |
Date of disclosure of the study information | 2021/04/16 |
Last modified on | 2020/07/10 10:27:27 |
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
Efficacy
Area under the curve of blood glucose level
Fasting blood glucose level
Postprandial blood glucose level (30, 60, 90, 120 min)
maximum blood glucose level
Fasting blood insulin level
Postprandial blood insulin level (30, 60, 90, 120 min)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of test food (single ingestion)-washing out (7 days or more)-intake of placebo (single ingestion)
Intake of placebo (single ingestion)-washing out (7 days or more)-intake of test food (single ingestion)
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Healthy males and females from 20 to 64 years of age
(2) Blood glucose level at postprandial 30 minitues is ranged from 140 mg/dL to 199 mg/dL
(1) Subjects who have a habit of continuously ingesting mulberry (including mulberry tea).
(2) Subjects who routinely take foods or medicines affecting the test result.
(3) Subjects who have a disease requiring regular medication.
(4) Subjects who are under treatment or have a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease).
(5) Ineligible subjects with abnormal laboratory value or cardiopulmonary function.
(6) Subjects having possibilities for emerging allergy related to the study.
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(8) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas.
(9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(10) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
(11) Subjects judged as unsuitable for the study by the investigator for other reasons.
30
1st name | Yoshihiro |
Middle name | |
Last name | Kojima |
Minato Pharmaceutical co., Ltd.
Sales department
104-0061
1-14-11, Ginza, Chuo-ku, Tokyo
03-3564-3710
kojima@minato-p.com
1st name | Shingo |
Middle name | |
Last name | Yamamichi |
TTC Co., Ltd.
Clinical Research Planning Department
150-0021
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
s.yamamichi@ttc-tokyo.co.jp
TTC Co., Ltd
Minato Pharmaceutical co., Ltd.
Profit organization
Aisei Hospital Ueno Clinic Research Ethics Committee
2-18-6, Higashiueno, Taitou-ku, Tokyo
03-6455-0880
t.saito@ttc-smo.jp
NO
2021 | Year | 04 | Month | 16 | Day |
Unpublished
Completed
2020 | Year | 02 | Month | 13 | Day |
2020 | Year | 02 | Month | 13 | Day |
2020 | Year | 02 | Month | 18 | Day |
2020 | Year | 04 | Month | 17 | Day |
2020 | Year | 02 | Month | 17 | Day |
2020 | Year | 07 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045057
Research Plan | |
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