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 |
A study to verify the anti-obesity effects of the test food consumption
A study to verify the anti-obesity effects of the test food consumption
A study to verify the anti-obesity effects of the test food consumption: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A study to verify the anti-obesity effects of the test food consumption
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the anti-obesity effects of test product consumption.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of body mass index (BMI) at 12 weeks after intervention (12w)
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Educational,Counseling,Training
Food |
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.
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.
18 | years-old | <= |
Not applicable |
Male and Female
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
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
80
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
03-3818-0610
nao@orthomedico.jp
Bio Actives Japan Corporation.
Bio Actives Japan Corporation.
Profit organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@takara-clinic.com
NO
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)
2025 | Year | 07 | Month | 02 | Day |
Unpublished
Open public recruiting
2025 | Year | 06 | Month | 24 | Day |
2025 | Year | 06 | Month | 24 | Day |
2025 | Year | 07 | Month | 02 | Day |
2025 | Year | 12 | Month | 13 | Day |
<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
2025 | Year | 07 | Month | 02 | Day |
2025 | Year | 07 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066696