UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058345
Receipt number R000066696
Scientific Title A study to verify the anti-obesity effects of the test food consumption: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2025/07/02
Last modified on 2025/07/02 14:08:39

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Basic information

Public title

A study to verify the anti-obesity effects of the test food consumption

Acronym

A study to verify the anti-obesity effects of the test food consumption

Scientific Title

A study to verify the anti-obesity effects of the test food consumption: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

A study to verify the anti-obesity effects of the test food consumption

Region

Japan


Condition

Condition

Healthy Japanese

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the anti-obesity effects of test product consumption.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. The measured value of body mass index (BMI) at 12 weeks after intervention (12w)

Key secondary outcomes

1. The amount and percentage of change in BMI from screening (Scr) at 12w

2. The measured values of body weight, body fat percentage, lean body mass, muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), and waist circumference at 12w, and their amount and percentage of changes from Scr

3. The measured values of "sleepiness on rising (Zc score)," "initiation and maintenance of sleep (Zc score)," "frequent dreaming (Zc score)," "refreshing (Zc score)," "sleep length (Zc score)," Chalder Fatigue Scale (CFS) total score, physical fatigue score, and mental fatigue score at 12w

4. The measured values of the defecation frequency, defecation days, and the amount of defecation in period 2~13*

5. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 2~13 compared to period 1*

6. Individuals whose response to "not good at relieving tension," "nerves are quite sensitive," "cannot relax," "do not feel positive," "no feeling of satiety after eating," "no feeling of fullness after eating," "no feeling of hunger before eating," "skin is rough," "skin is itchy," "wrinkles are noticeable," "stains are noticeable," "acne is noticeable," "pores are noticeable," "skin is dry," "face is swollen," "skin lacks firmness and elasticity," "skin lacks clarity," and "makeup does not apply well" improved by one or more scales at 12w compared to Scr

7. The measured values of Pain, Water Reten, Auto React, Neg Affect, Impair Conc, Behave Change, Arousal, and Control at 12w, and their amount and percentage of changes from before intervention

8. Individuals whose response to each item in the Menstrual Distress Questionnaire (MDQ) improved by one or more scales at 12w compared to before intervention

*Period 1: 7 days prior to Scr
*Period 2~13: 7-day periods from day 1 to day 84 of the intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test product: SG-1
Administration: Take one tablet with water 30 minutes before each meal (breakfast, lunch, and dinner), for a total of three tablets per day.

*The daily dose should be taken within the day with food. If a dose is missed, take it as soon as you remember within that day. Even if you have no meal, take the test food.

Interventions/Control_2

Duration: 12 weeks
Test product: Placebo
Administration: Take one tablet with water 30 minutes before each meal (breakfast, lunch, and dinner), for a total of three tablets per day.

*The daily dose should be taken within the day with food. If a dose is missed, take it as soon as you remember within that day. Even if you have no meal, take the test food.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose BMI is 23 or more and less than 30 at Scr

6. Individuals whose waist circumference is relatively large at Scr

Key exclusion criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to herbs

7. Individuals who are pregnant, lactating, or planning to become pregnant during this study

8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

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

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

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

TEL

03-5793-3623

Email

t-takara@takara-clinic.com


Public contact

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


Sponsor or person

Institute

Bio Actives Japan Corporation.

Institute

Department

Personal name



Funding Source

Organization

Bio Actives Japan Corporation.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

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

Tel

03-5793-3623

Email

IRB@takara-clinic.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2025 Year 07 Month 02 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2025 Year 06 Month 24 Day

Date of IRB

2025 Year 06 Month 24 Day

Anticipated trial start date

2025 Year 07 Month 02 Day

Last follow-up date

2025 Year 12 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

<Statistical analysis details>
The subgroups will be constructed based on the factors in the following variables.

Gender: Male / female
Age: less than 40 / 40 or more
BMI: 23 or more and less than 25 / 25 or more and less than 30


Management information

Registered date

2025 Year 07 Month 02 Day

Last modified on

2025 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066696