UMIN-CTR Clinical Trial

Basic information
Public title	Effects of fermented dairy product on glucose metabolism in pre-diabetic subjects: a double blind, placebo-controlled study
Acronym	Effects of fermented dairy product in pre-diabetic subjects
Scientific Title	Effects of fermented dairy product on glucose metabolism in pre-diabetic subjects: a double blind, placebo-controlled study
Scientific Title:Acronym	Effects of fermented dairy product in pre-diabetic subjects
Region	Japan

Condition
Condition	impaired glucose tolerance
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effects of ingestion of fermented dairy product containing lactic acid bacteria for 8 consecutive weeks on glucose metabolism in men with body mass index >= 25 and impaired glucose tolerance (IGT).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glucose tolerance (maximum plasma glucose level, area under the curve of plasma glucose, glucose spike (the difference between maximum plasma glucose and fasting plasma glucose), and plasma levels of glucose (30, 60, 90 and 120 min) during 75-g oral glucose tolerance test (OGTT)) The effects on the primary outcomes are evaluated not only in all subjects but also in the subgroup with impaired early insulin responses (insulinogenic index <0.4).
Key secondary outcomes	fasting plasma glucose, insulinogenic index (II),homeostasis model assessment of beta-cell function (HOMA-beta), Matsuda index, homeostasis model assessment-insulin resistance (HOMA-IR), serum insulin level during OGTT, glycoalbumin, HbA1c, serum cholesterol level (non-HDL cholesterol, LDL cholesterol, total cholesterol, and HDL cholesterol) The effects on the secondary outcomes are evaluated not only in all subjects but also in the subgroup with impaired early insulin responses (insulinogenic index <0.4).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	fermented dairy product containing lactic acid bacteria
Interventions/Control_2	placebo (non-fermented dairy product)
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
Key inclusion criteria	1) An age 20 years or older and up to 64 years 2) A BMI of 25 or more 3) A 1-hour plasma glucose level during OGTT of 180 mg/dL or more 4) A 2-hour plasma glucose level during OGTT of about 140 to 199 mg/dL
Key exclusion criteria	1) Subjects who consume lactic acid bacteria beverage, lactic acid bacteria -rich food or lactic acid bacteria preparation more than 3 times a week 2) Subjects routinely taking medicine or health food which may influence glucose metabolism 3) Subjects who are under medication which may influence the outcome of the study 4) Subjects with a history of serious disease, e.g., liver disease, kidney disease, hypertension, or ischemic heart disease 5) Subjects with allergies to dairy products used in the study 6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination 7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 9) Subjects who are judged as unsuitable for the study by physician for other reason
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takayuki Ishikawa
Organization	Nishi-Shinjyuku Kisaragi Clinic
Division name	none
Zip code
Address	6-6-2 Nishishinjuku, Sinjuku-ku, Tokyo
TEL	03-3344-0529
Email	saiyo@kisa-cl.com

Public contact
Name of contact person	1st name Middle name Last name Hiroyasu Shimada
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code
Address	1-20-2 Ebisunishi, shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	ttcpwr2001@ttc-tokyo.co.jp

Sponsor
Institute	Nishi-Shinjyuku Kisaragi Clinic
Institute
Department

Funding Source
Organization	TTC Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
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Email

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	2013 Year 11 Month 29 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	Completed
Date of protocol fixation	2013 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date	2013 Year 09 Month 02 Day
Last follow-up date	2013 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 29 Day
Last modified on	2014 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014558

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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