UMIN-CTR Clinical Trial

Public title

Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -

Acronym

A clinical trial to study the effect of Bifidobacterium on VFA reduction.

Scientific Title

Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -

Scientific Title:Acronym

A clinical trial to study the effect of Bifidobacterium on VFA reduction.

Region

Japan

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of the Bifidobacterium preparation on visceral fat area in the subjects with abdominal obesity.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Visceral Fat Area(VFA)

Key secondary outcomes

Body Weight, BMI, Subcutaneous fat area(SFA), Total fat area(TFA),Body fat percentage

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Test food contained Bifidbacterium and N-acetylglucosamine, 4 capsules once day for 12weeks.

Interventions/Control_2

Control food not contained Bifidbacterium and N-acetylglucosamine, 4 capsules once a day for 12weeks.

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1)BMI 25 - 30 kg/m2
2)Subjects who giving written informed consent

Key exclusion criteria

1)Subjects who take drug including Bifidbacterium or drug having an effect on intestinal functions.
2)Subjects who consecutively take dietary supplement or food including Bifidbacterium (more than three times a week for more than half year), and can't stop those foods during the test period.
3)Subjects who consecutively take dietary supplement or food including N-acetylglucosamine (more than three times a week for more than half year), and can't stop those foods during the test period.
4)Subjects who constantly use drugs and/or Kampo preparation and/or dietary supplement affecting the body fat.
5)Subjects who have colonic disease within 10 years (except polyp or infectious colitis).
6)Subjects who take medical treatment for obesity-related disease. (glucose intolerance, dyslipidemia, hypertension, hyperuricemia, gout, coronary artery disease, cerebral infarction, fatty liver, menstrual abnormality, sleep apnea syndrome, obesity hypoventilation syndrome, orthopedic disease, obesity-related renal disease)
7)Subjects who have severe disorders in liver function and/or kidney function.
8)Subjects who have medical history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, enterectomy, etc.).
9)Subjects who have allergy to medicine, shrimp, crab, milk or egg.
10)Subjects who can't discontinue dietary supplements for test period.
11)Subjects who are planned to participate in other clinical study.
12)Female with pregnancies, lactating or planning to become pregnant during the study.
13)Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kei Yui

Organization

FANCL Corporation

Division name

Research Institute

Zip code

Address

12-13 Kamishinano, Totuska-ku, Yokohama, kanagawa, Japan

TEL

045-820-3522

Email

ke-yui@fancl.co.jp

Name of contact person

1st name
Middle name
Last name	Isao Takehara

Organization

Clinical Support Corporation

Division name

PI Food Service Division

Zip code

Address

4-1South 1 West 8, Chuo-ku, Sappori, 060-0061, Japan

TEL

011-223-3130

Homepage URL

Email

takehara@csc-smo.co.jp

Institute

Clinical Support Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

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

医療法人北武会　美しが丘病院（北海道）
Medical Corporation Hokubukai Utsukushigaoka Hospital

Date of disclosure of the study information

2016

Year

12

Month

01

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

2015

Year

12

Month

10

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

05

Day

Last modified on

2016

Year

10

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023605