Unique ID issued by UMIN | UMIN000047804 |
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Receipt number | R000054498 |
Scientific Title | Study of the glucose metabolism-improving effect of the 12-week intake of yogurt containing heat-treated lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2022/05/20 |
Last modified on | 2023/08/01 11:47:22 |
Study of the glucose metabolism-improving effect of the 12-week intake of test food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Study of the glucose metabolism-improving effect of test food containing lactic acid bacteria
Study of the glucose metabolism-improving effect of the 12-week intake of yogurt containing heat-treated lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Study of the glucose metabolism-improving effect of yogurt containing heat-treated lactic acid bacteria
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
HbA1c
Fasted blood glucose
Blood glucose after glucose loading
Glycoalbumin
Fasted blood insulin
Blood insulin after glucose loading
Insulin resistance indexes (HOMA-IR, QUICKI)
Blood 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
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. 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 or lactose intolerance
5. Subjects who were diagnosed with diabetes by the screening test
6. Subjects who have been suffering from or under treatment of 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 were collected or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test
10. Subjects who drink a lot of alcohol
11. Subjects who have been drug dependency
12. Subjects who participated in other clinical trials within one month before the agreement of participants in this study
13. Subjects engaged in day/night shift work
14. Subjects who are in pregnancy, in nursing or williing to be pregnant during the test period
15. Subjects who are judged as unsuitable for the study by the investigator for other reasons
150
1st name | Yoshitaka |
Middle name | |
Last name | Iwama |
Nihonbashi Cardiology Clinic
director
103-0001
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
81-3-5641-4133
yiwama@well-sleep.jp
1st name | Eiji |
Middle name | |
Last name | Yoshikawa |
KSO Corporation
Sales department
105-0023
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
81-3-3452-7733
eigyou27@kso.co.jp
KSO Corporation
Meiji Co., Ltd.
Profit organization
Japan
Ethical Committee of Nihonbashi Cardiology Clinic
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
81-3-5641-4133
niho-jimucho@well-sleep.jp
NO
2022 | Year | 05 | Month | 20 | Day |
Unpublished
148
Completed
2022 | Year | 03 | Month | 14 | Day |
2022 | Year | 03 | Month | 14 | Day |
2022 | Year | 06 | Month | 24 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 04 | Month | 10 | Day |
2023 | Year | 04 | Month | 10 | Day |
2023 | Year | 05 | Month | 31 | Day |
2022 | Year | 05 | Month | 19 | Day |
2023 | Year | 08 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054498
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