Unique ID issued by UMIN | UMIN000032837 |
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Receipt number | R000037435 |
Scientific Title | Study of the glucose metabolism-improving effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2018/08/17 |
Last modified on | 2019/06/03 10:21:24 |
Study of the glucose metabolism-improving effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Study of the glucose metabolism-improving effect of test food
Study of the glucose metabolism-improving effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Study of the glucose metabolism-improving effect of test food
Japan |
Hyperglycemia
Medicine in general | Endocrinology and Metabolism | Adult |
Others
NO
To examine the effect of improving glucose metabolism by the intake of lactic acid bacteria
Efficacy
Confirmatory
Explanatory
Phase II,III
Fasted blood glucose, HbA1c
Fasted blood insulin
Insulin resistance indexes (HOMA-IR, QUICKI)
Glycoalbumin
Blood inflammatory cytokines, hsCRP
Blood adiponectin
Blood lipids
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Prevention
Food |
12-week intake of the test food
12-week intake of the placebo food
20 | years-old | <= |
64 | years-old | >= |
Male and Female
1. Subjects giving written informed consent
2. Healthy men and women of 20 to 64 years age
3. Fasted blood glucose levels were 100 to 125 mg/dL and blood HbA1c levels were 5.6 to 6.4 % at the screening period
1. Subjects who take the medicine affecting blood glucose levels
2. Subjects with a habit of taking supplements or health food affecting blood glucose levels in one month before the screening test
3. Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in one month before the screening test
4. Subjects with milk allergy
5. Subjects who were diagnosed with diabetes requiring medication by the screening test
6. Sever systemic diseases affecting the results of this study
7. Subjects who have chronic illness and who take medication everyday
8. Subjects who were judged unsuitable as subjects by clinical examination at the screening test
9. Subjects who donated blood of more than 200 mL within a month or more than 400 mL within 3 months
10. Subjects who drink a lot of alcohol
11. Subjects who have been drug dependency or alcohol dependency
12. Subjects who participated in other clinical trials within one month before the agreement of participants in this study
13. Subjects in pregnancy or in nursing
14. Subjects who are judged as unsuitable for the study by the investigator for other reasons
130
1st name | |
Middle name | |
Last name | Satoru Suzuki |
Shinagawa Season Terrace Health Care Clinic
Medical examination and treatment management family chief director
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
81-3-3452-3381
satoru_suzuki@sempos.or.jp
1st name | |
Middle name | |
Last name | Eiji Yoshikawa |
KSO Corporation
Facility Management Department
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
81-3-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
Meiji Co., Ltd.
Profit organization
Japan
NO
2018 | Year | 08 | Month | 17 | Day |
Unpublished
Completed
2018 | Year | 06 | Month | 01 | Day |
2018 | Year | 06 | Month | 01 | Day |
2018 | Year | 08 | Month | 17 | Day |
2018 | Year | 11 | Month | 18 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 03 | Month | 31 | Day |
2018 | Year | 06 | Month | 01 | Day |
2019 | Year | 06 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037435
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