UMIN-CTR Clinical Trial

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

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