UMIN-CTR Clinical Trial

Public title

Examination study on abdominal visceral fat reducing action by functional food intake
-Randomized placebo-controlled double-blind parallel group comparison study-

Acronym

Examination study on abdominal visceral fat reducing action by functional food intake

Scientific Title

Examination study on abdominal visceral fat reducing action by functional food intake
-Randomized placebo-controlled double-blind parallel group comparison study-

Scientific Title:Acronym

Examination study on abdominal visceral fat reducing action by functional food intake

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of intake of functional food for 12 weeks on abdominal fat area reduction and safety in males and females with abdominal obesity aged 20-64

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

<Efficacy>
Abdominal visceral fat area, at 8 and 12 weeks after intake
<Safety>
Side effect incidence

Key secondary outcomes

<Efficacy>
Abdominal subcutaneous fat area and abdominal whole fat area, at 8 and 12 weeks after intake
Waist circumference diameter, hip circumference diameter, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, and fasting blood glucose at 4,8 and 12 weeks after intake
HbA1c and adiponectin at 12 weeks after intake
<Safety>
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

YES

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 12 weeks

Interventions/Control_2

Intake of placebo food 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 of age
2. Subjects equal to or more than 24 and less than 30 kg/m^2 of BMI
3. Subjects who recognize the object and contents of the study and submit the written informed consent

Key exclusion criteria

1. Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs
2. Subjects who fall under the
diagnostic criteria of metabolic syndrome
3. Subjects who received medication treatment or surgery due to serious illness or injury within 2 months from the start of this study
4. Subjects who use drugs of
glycometabolism, lipidmetabolism, or reducing high blood pressure
5. Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study except who agree to quit taking them
6. Pregnant and lactating female, or who wish to get pregnant during the study period
7. Heavy dinkers
8. Subjects who feel bad mood by blood collection in past
9. Subjects who donated 200 mL or more of blood within 1 month from the start of the test or subjects who plan to do so during the test period
10. Subjects who have been
constipated for more than 5 days
11. Shift worker
12. Subjects who have allergy related to the test foods
13. Subjects already participating in other clinical trials, subjects
planning to participate during this examination period
14. Subjects who can not agree with the purpose of this test conducted in advance
15. Subjects who are ineligible due to physician's judgment

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Ikuo Fukuhara

Organization

Fukuhara Clinic

Division name

Hospital director

Zip code

Address

3-1-15 Shimamatsuhigashi-machi Eniwa, Hokkaido, Japan

TEL

0123-36-8029

Email

i-feniwa@gray.plala.or.jp

Name of contact person

1st name
Middle name
Last name	Tomita Shimpei

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

s-tomita@ndrcenter.co.jp

Institute

Maruzen Pharmaceuticals Co., Ltd.

Institute

Department

Personal name

Organization

Maruzen Pharmaceuticals 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

2017

Year

04

Month

07

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

2017

Year

02

Month

23

Day

Date of IRB

Anticipated trial start date

2017

Year

04

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

02

Month

24

Day

Last modified on

2017

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030198