UMIN-CTR Clinical Trial

Public title

A Study on the Effects of the Test Food on Visceral Fat Reduction -A Randomized, Double-blind, Placebo-controlled Parallel-group Study

Acronym

A Study on the Visceral Fat Reduction Effects of the Test Food

Scientific Title

A Study on the Effects of the Test Food on Visceral fat Reduction -A Randomized, Double-blind, Placebo-controlled Parallel-group Study-

Scientific Title:Acronym

A Study on the Visceral Fat Reduction Effects of the Test Food

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of continuous 12-week intake of the test food on abdominal visceral fat reduction in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Amount of change of abdominal visceral fat area at 12 weeks

Key secondary outcomes

Abdominal visceral fat area
Abdominal subcutaneous fat area
Abdominal total fat area
Body weight
Body Mass Index (BMI)
Body fat percentage
Body fat amount
Lean mass
Muscle mass
Waist circumference
Waist-to-Hip ratio

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

Prevention

Type of intervention

Food

Interventions/Control_1

Consumption of the test food (1 pack a day, 12 weeks)

Interventions/Control_2

Consumption of the placebo food (1 pack a day, 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) Healthy subjects aged of 20-64 years
2) Subjects whose BMI is 25 kg/m2 or more and less than 30 kg/m2 at first screening test
3) Subjects who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate on good understanding, and have agreed to participate in the study in writing

Key exclusion criteria

1) Subjects who use habitually medications (including intestinal regulators and laxatives. However, subjects who can stop taking intestinal regulators from the first screening test until the end of this study are permitted.)
2) Subjects who have a current history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease (excluding transient treatment such as colds)
3) Subjects who have a digestive disease that affects digestion and absorption, or a history of surgery (excluding appendicitis)
4) Subjects who have a history or current medical history of drug dependence or alcoholism
5) Subjects who have been diagnosed with familial hyperlipidemia
6) Subjects who are diagnosed with chronic constipation
7) Subjects who are unable to stop taking health foods and supplements (including foods for specified health uses and foods with functional claims) that may affect this study
8) Subjects who have a habit of drinking excessively (drinking more than 20 g of pure alcohol equivalent per day, at least 4 days a week)
9) Subjects who have a habit of smoking excessively (smokers of 21 cigarettes or more per day)
10) Subjects who are wearing a medical device necessary for life support, such as a cardiac pacemaker, implantable cardioverter defibrillator, or biological information monitor
11) Subjects who have a contagious disease or an injury to the palms or the soles of the feet
12) Subjects who have metal in the CT scan measurement site due to surgery, etc.
13) Subjects who are claustrophobic
14) Subjects who have reported that they are allergic to the ingredient in test foods
15) Subjects who have extremely irregular eating habits, shift workers (excluding daytime shift work), or late-night workers

Target sample size

120

Name of lead principal investigator

1st name	Daisuke
Middle name
Last name	Tsuge

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Doctor

Zip code

108-0075

Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

TEL

03-3452-3382

Email

shibaura@sempos.or.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numazu

Organization

KSO Corporation

Division name

Clinical Trial Management department

Zip code

105-0023

Address

1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Morishita Jintan Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17 Joto-machi, Maebashi-shi, Gunma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp

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

2025

Year

11

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

Preinitiation

Date of protocol fixation

2025

Year

08

Month

09

Day

Date of IRB

2025

Year

08

Month

21

Day

Anticipated trial start date

2025

Year

10

Month

14

Day

Last follow-up date

2026

Year

04

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Continued Key exclusion criteria)
16) Subjects whose exercise habits are likely to change significantly during this study, who regularly engage in strenuous exercise (exercise that makes conversation difficult), and are going on a diet
17) Subjects who are planning to travel overseas, take long-term domestic business trips or travel (more than 10 days per month), or be transferred during this study.
18) Subjects who are pregnant or lactating, or intending to become pregnant during this study.
19) Subjects who are participating in other food, drug, or cosmetic studies, or who participated or plan to participate in any study within one month prior to consent.
20) Subjects who have donated more than 200 mL of blood and/or component blood within one month or more than 400 mL within three months prior to the screening test
21) Subjects who are judged by the principal investigator to be ineligible for study participation based on the screening tests
22) Subjects who are judged by the principal investigator to be ineligible for study participation for other reason

Registered date

2025

Year

11

Month

01

Day

Last modified on

2025

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068164