UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial

Acronym

Effects of consumption of the test food in healthy Japanese normal to overweight subjects

Scientific Title

Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial

Scientific Title:Acronym

Effects of consumption of the test food in healthy Japanese normal to overweight subjects

Region

Japan

Condition

Japanese subjects between 23 kg/m² or more and less than 30 kg/m² in body mass index (BMI)

Classification by specialty

Not applicable	Adult	Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the visceral fat reducing effect with the consumption of the test food for 12 weeks in Japanese adult subjects between 23 kg/m² or more and less than 30 kg/m² in BMI

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 in a cross section of the umbilical region

* Assess the fat area by X-ray CT
* Calculate the amount of change between screening (before consumption) and 12 weeks after consumption

Key secondary outcomes

1. Total fat area
2. Subcutaneous fat area
3. Visceral fat area
4. Serum adiponectin level
5. Serum total cholesterol level
6. Serum HDL-cholesterol level
7. Serum LDL-cholesterol level
8. Serum neutral fat (TG: triglyceride) level
9. Serum glucose level
10. Height
11. Body weight
12. Body mass index
13. Body fat percentage
14. Body temperature
15. Abdominal circumference
16. Muscle mass
17. Basal metabolic rate
18. Subjective symptoms (A questionnaire)

*^{1-9, 11-18} Assess these tests at screening (before consumption) and at 12 weeks after consumption
*¹⁰ Measure the height only at screening (before consumption)
*^1-2 Assess these by X-ray CT. Measure the fat area of umbilicus cross section and calculate the amount of change between screening (before consumption) and 12 weeks after consumption.
*³ Assess the measured value of the fat area in a cross section of the umbilical region by X-ray CT.
*^{4-9, 11-17} Measure the items and calculate the amount of change between screening (before consumption) and 12 weeks after consumption.
*¹⁸ Assess symptoms by the Likert scale. Each item is assessed with a six-point grading scale from 1 (strongly disagree) to 6 (strongly agree). The smaller number indicates better condition.

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

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test material: Capsules containing malted rice
Dose: Take 2 capsules per day
Administration: Take 2 capsules with water or warm water after breakfast

* If you forget to take capsules, take these as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test material: Placebo capsule
Dose: Take 2 capsules per day
Administration: Take 2 capsules with water or warm water after breakfast

* If you forget to take capsules, take these as soon as you remember within the day.

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

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. Within the subjects who met the 1st and 2nd inclusion criteria, subjects whose visceral fat area of umbilicus cross section are relatively large

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders

2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, 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

20

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

HEALTH UP INC.

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

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

22

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

08

Month

06

Day

Date of IRB

2018

Year

08

Month

06

Day

Anticipated trial start date

2018

Year

08

Month

20

Day

Last follow-up date

2019

Year

02

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

08

Month

10

Day

Last modified on

2020

Year

08

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038431