UMIN-CTR Clinical Trial

Public title

Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage
- Randomized placebo-controlled double-blind parallel group comparison study -

Acronym

Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage

Scientific Title

Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage
- Randomized placebo-controlled double-blind parallel group comparison study -

Scientific Title:Acronym

Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage

Region

Japan

Condition

Not applicable

Classification by specialty

Clinical immunology	Oto-rhino-laryngology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of decreasing VFA (Visceral fat area) level by ingestion of the the food containing indigestible dextrin

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy
Visceral fat area

Key secondary outcomes

Efficacy
Total fat area, subcutaneous fat area, body weight, BMI, Triglycerides, glycometabolism relation items
Safety
Side effect incidence,Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items

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. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of test food(350mL)of 3 bottles of test beverage per day for 12 weeks

Interventions/Control_2

Intake of placebo food(350mL)of 3 bottles of test beverage per day for 12 weeks

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 Males and females equal to or more than 20 years and less than 65 years old
2 Subjects with equal to or more than 23 and less than 30 kg/m^2 of BMI at the 1st screening test

Key exclusion criteria

1 Subjects who received medication treatment or surgery due to serious illness or injury within 1 months from the start of this study
2 Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs
3 Subjects who medicine for glycometabolism, lipidmetabolism, or reducing high blood pressure
4 Subjects who regularly use over-the-counter medicine, health foods, supplements which are suggested causal relationship from the screening test
5 Pregnant and lactating female, or who wish to get pregnant during the study period
6 Heavy drinkers
7 Individual donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study
8 Subjects who are planned to change their life style or maitain irregular life during study period
9 Subjects who cannot follow test sample intake condition by the protocol
10 Subjects already participating in other clinical trials, subjects planning to participate during this examination period
11 Subjects who are ineligible due to physician's judgment

Target sample size

140

Name of lead principal investigator

1st name
Middle name
Last name	Kiyohisa Kaneko

Organization

Coca-Cola (Japan) Company, limited

Division name

Academic Director

Zip code

Address

6-3,Shibuya,4-chome,shibuyaku,Tokyo,Japan

TEL

03-5466-8000

Email

kkaneko@coca-cola.com

Name of contact person

1st name
Middle name
Last name	Yoshitaka Hatakeyama

Organization

New Drug Research Center, Inc.

Division name

Clinical Research Dept.

Zip code

Address

452-1Toiso,Eniwa-shi,Hokkaido, Japan

TEL

0123-34-0412

Homepage URL

Email

y-hatakeyama@ndrcenter.co.jp

Institute

Coca-Cola (Japan) Company, limited
Matsutani Chemical Industry co.,ltd

Institute

Department

Personal name

Organization

Coca-Cola (Japan) Company, limited
Matsutani Chemical Industry 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

2018

Year

05

Month

08

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

2018

Year

02

Month

07

Day

Date of IRB

2018

Year

02

Month

06

Day

Anticipated trial start date

2018

Year

04

Month

16

Day

Last follow-up date

2018

Year

08

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

05

Month

08

Day

Last modified on

2019

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=R000037077