UMIN-ICDS Clinical Trial

Public title

A verification study of the anti-obesity effect of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial

Acronym

A verification study of the anti-obesity effect of the test food

Scientific Title

A verification study of the anti-obesity effect of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial

Scientific Title:Acronym

A verification study of the anti-obesity effect of the test food

Region

Japan

Condition

Japanese subjects between 23 kg/m² or more and less than 30 kg/m² in BMI

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the visceral fat reducing effect with the consumption of the test food for 8 weeks

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The visceral fat area of umbilicus cross section

* Assessed the fat area by X-ray CT
* Calculate the amount of change between before consumption and 8 weeks after consumption

Key secondary outcomes

1. Total fat area
2. Subcutaneous fat area
3. Visceral fat area
4. Serum adiponectin
5. Serum total cholesterol
6. Serum HDL cholesterol
7. Serum LDL cholesterol
8. Serum neutral fat (TG: triglyceride)
9. Serum glucose
10. Serum levels of glyceraldehyde-derived advanced glycation end-products
11. Plasma amyloid beta
12. Serum epidermal growth factor
13. Body weight
14. Body mass index
15. Body fat percentage
16. Abdominal circumference
17. Subjective symptoms

*^1-3 Assessed these by X-ray CT
*¹⁷ Assessed these symptoms by the Likert scale
*^1-3 Measure the fat area of umbilicus cross section and calculate the amount of change between before consumption and 8 weeks after consumption. Visceral fat area value will be only measured.
*^1-17 Assess these tests at screening and examination before consumption and at 4 and 8 weeks after consumption

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 8 weeks
Test material: Test food A
Dose: Take 3 tablets per day
Administration: Take the tablet with a glass of water before each meal

* If you forget to take the tablet, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 8 weeks
Test material: Test food B
Dose: Take 3 tablets per day
Administration: Take the tablet with a glass of water before each meal

* If you forget to take the tablet, take it as soon as you remember within the day.

Interventions/Control_3

Duration: 8 weeks
Test material: Placebo
Dose: Take 3 tablets per day
Administration: Take the tablet with a glass of water before each meal

* If you forget to take the tablet, take it as soon as you remember within the day.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese adult subjects between 23 kg/m² or more and less than 30 kg/m² in BMI

2. Subjects who are judged as eligible to participate in the study by the physician

3. Subjects who are between 23 kg/m² or more and less than 25 kg/m² in BMI or between 25 kg/m² or more and less than 30 kg/m² in BMI with less than 100 cm² in the visceral fat area at screening

4. Within the subjects who met the 2nd and 3rd inclusion criteria, subjects who are relatively high levels of blood glucose at screening

Key exclusion criteria

1. A medical history of malignant tumor, heart failure or myocardial infarction

2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

4. Subjects who have exercise habits more than 3 times per week

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, lactation, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

60

Name of lead principal investigator

1st name	Kazuo
Middle name
Last name	YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name	Naoko
Middle name
Last name	SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Toyo Sugar Refining Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

info@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Date of disclosure of the study information

2018

Year

05

Month

23

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/abs/10.1111/1750-3841.15429?af=R

Number of participants that the trial has enrolled

66

Results

Hashizume Y, Tandia M. The reduction impact of monoglucosyl rutin on abdominal visceral fat: A randomized, placebo-controlled, double-blind, parallel-group. Journal of Food Science 2020; 85(10): 3577-3589

Results date posted

2021

Year

05

Month

27

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

09

Month

16

Day

Baseline Characteristics

Refer to the paper

Participant flow

Refer to the paper

Adverse events

Refer to the paper

Outcome measures

Refer to the paper

Plan to share IPD

Undecided

IPD sharing Plan description

To require consultation among related companies

Recruitment status

Completed

Date of protocol fixation

2018

Year

05

Month

08

Day

Date of IRB

2018

Year

05

Month

08

Day

Anticipated trial start date

2018

Year

05

Month

24

Day

Last follow-up date

2018

Year

12

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

05

Month

23

Day

Last modified on

2021

Year

05

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037280