![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047804 |
Receipt No. | 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 | 2022/05/19 |
Basic information | ||
Public title | 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 | |
Acronym | Study of the glucose metabolism-improving effect of test food containing lactic acid bacteria | |
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 | |
Scientific Title:Acronym | Study of the glucose metabolism-improving effect of yogurt containing heat-treated lactic acid bacteria | |
Region |
|
Condition | ||||
Condition | Hyperglycemia | |||
Classification by specialty |
|
|||
Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the effect of improving glucose metabolism by the intake of lactic acid bacteria |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase |
Assessment | |
Primary outcomes | HbA1c |
Key secondary outcomes | 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 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
|
|
Interventions/Control_1 | 12-week intake of the test food | |
Interventions/Control_2 | 12-week intake of the placebo food | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 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 |
|||
Key exclusion criteria | 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 |
|||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Nihonbashi Cardiology Clinic | ||||||
Division name | director | ||||||
Zip code | 103-0001 | ||||||
Address | Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo | ||||||
TEL | 81-3-5641-4133 | ||||||
yiwama@well-sleep.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | KSO Corporation | ||||||
Division name | Sales department | ||||||
Zip code | 105-0023 | ||||||
Address | 1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building | ||||||
TEL | 81-3-3452-7733 | ||||||
Homepage URL | |||||||
eigyou27@kso.co.jp |
Sponsor | |
Institute | KSO Corporation |
Institute | |
Department |
Funding Source | |
Organization | Meiji Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Ethical Committee of Nihonbashi Cardiology Clinic |
Address | Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo |
Tel | 81-3-5641-4133 |
niho-jimucho@well-sleep.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054498 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |