Unique ID issued by UMIN | UMIN000035710 |
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Receipt number | R000040628 |
Scientific Title | A Study on the Effect of Food Containing Plant Extract on Postprandial Blood Glucose -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- |
Date of disclosure of the study information | 2019/02/01 |
Last modified on | 2021/02/17 10:43:41 |
A Study on the Effect of Food Containing Plant Extract on Postprandial Blood Glucose
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
A Study on the Effect of Food Containing Plant Extract on Postprandial Blood Glucose
A Study on the Effect of Food Containing Plant Extract on Postprandial Blood Glucose
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
A Study on the Effect of Food Containing Plant Extract on Postprandial Blood Glucose
Japan |
No
Adult |
Others
NO
To comfirm the effect of food containing plant extract on postprandial blood glucose
Efficacy
Blood glucose AUC
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Food containing plant extract, single ingestion. Wash out. Food not containing plant extract, single ingestion.
Food not containing plant extract, single ingestion. Wash out. Food containing plant extract, single ingestion.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1)Males and females aged 20 to 64 years-old.
(2)Subjects whose fasting blood glucose level is from 100 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 causal blood glucose level is under 200 mg/dL and who are judged normal-high or borderline type as the state of glycemia by the principal investigator.
(3) Subjects who do not habitually consume a large amounts of alcohol.
(4)Subjects who can make self-judgment and are voluntarily giving written informed consent.
(1) Subjects whose fasting blood glucose level is 126 mg/dL and over or two-hour blood glucose level after 75 g glucose loading is 200 mg/dL and over.
(2) Subjects who use medications affecting blood glucose level.
(3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood glucose level during test periods.
(4) Subjects who have declared allergic reaction to ingredients contained in test foods or loading foods.
(5) Subjects who are diagnosed as diabetes by the screening tests I or II.
(6) Subjects who contract, are under treatment for or have a history of serious diseases (e.g., kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(7) Subjects who have a chronic disease and regularly use medications.
(8) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(9) Subjects who are judged unsuitable for the current study by the screening tests.
(10) Subjects who are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling.
(11) Subjects who have had diarrhea within the last one week prior to the screening tests.
(12) Subjects who have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(13) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(14) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study.
(15) Subjects who are planning to become pregnant after informed consent, pregnant or lactating.
(16) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
50
1st name | Yoshitaka |
Middle name | |
Last name | Iwama |
Nihonbashi Cardiology Clinic
Director
103-0001
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
yiwama@well-sleep.jp
1st name | Yoshika |
Middle name | |
Last name | Komori |
KSO Corporation
Sales department
105-0023
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshi@kso.co.jp
KSO Corporation
TOYO SHINYAKU Co., Ltd.
Profit organization
Ethical Committee of Nihonbashi Cardiology Clinic
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
niho-jimucho@well-sleep.jp
NO
2019 | Year | 02 | Month | 01 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040628
Published
http://www.pieronline.jp/content/article/0386-3603/47080/1245
50
Statistically significant difference was confirmed in the primary outcome.
2020 | Year | 04 | Month | 17 | Day |
Males and females aged 20 to 64 years old.
Enrolled(n=50)
Completed(n=49)
Analysed(n=46)
No adverse events were observed that be related to test food.
Blood glucose AUC
Main results already published
2018 | Year | 12 | Month | 25 | Day |
2019 | Year | 01 | Month | 11 | Day |
2019 | Year | 02 | Month | 02 | Day |
2019 | Year | 04 | Month | 18 | Day |
2019 | Year | 01 | Month | 29 | Day |
2021 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040628
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