UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Japan

Condition
Condition Hyperglycemia
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
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
Food
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
20 years-old <=
Age-upper limit
64 years-old >=
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
1st name Yoshitaka
Middle name
Last name Iwama
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
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yoshikawa
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
Email 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
Email 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
2022 Year 05 Month 20 Day

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
2022 Year 03 Month 14 Day
Date of IRB
2022 Year 03 Month 14 Day
Anticipated trial start date
2022 Year 06 Month 24 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2023 Year 04 Month 10 Day
Date trial data considered complete
2023 Year 04 Month 10 Day
Date analysis concluded
2023 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2022 Year 05 Month 19 Day
Last modified on
2022 Year 05 Month 19 Day


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


Contact us.