UMIN-CTR Clinical Trial

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

impaired glucose tolerance

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nishi-Shinjyuku Kisaragi Clinic

Institute

Department

Personal name

Organization

TTC Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

11

Month

29

Day

Last modified on

2014

Year

06

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014558