Unique ID issued by UMIN | UMIN000034316 |
---|---|
Receipt number | R000039120 |
Scientific Title | Effects of consumption of the test food on body fat: a randomized, double-blind, placebo-controlled, parallel-group trial |
Date of disclosure of the study information | 2018/09/28 |
Last modified on | 2020/02/03 10:03:52 |
Effects of consumption of the test food on body fat: a randomized, double-blind, placebo-controlled, parallel-group trial
Effects of consumption of the test food on body fat
Effects of consumption of the test food on body fat: a randomized, double-blind, placebo-controlled, parallel-group trial
Effects of consumption of the test food on body fat
Japan |
Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
Medicine in general | Adult |
Others
NO
To verify the effect on body fat 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
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
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
1. Total fat area
2. Subcutaneous fat area
3. Visceral fat area
4. Body weight
5. Body mass index
6. Body fat percentage
7. Lean body mass
8. Muscle mass
9. Abdominal circumference
10. Basal metabolic rate
11. Abdominal obesity ratio
*1-3 Assess these by X-ray CT
*1-11 Conduct these at screening (before consumption) and 4, 8, and 12 weeks after consumption.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: 12 weeks
Test material: Active capsule
Dose and Administration: Take one capsule per day after breakfast with water or lukewarm water
* If you forget to take the capsule, take it as soon as you remember within the day.
Duration: 12 weeks
Test material: Placebo capsule
Dose and Administration: Take one capsule per day after breakfast with water or lukewarm water
* If you forget to take the capsule, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese adult subjects
2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI
3. Subjects who are judged as eligible to participate in the study by the physician
4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects whose visceral fat area assessed by X-ray CT are relatively large
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. 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
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
5. Subjects who excessive exercise
6. Subjects who are currently taking medications (including herbal medicines) and supplements
7. Subjects who could have any allergens in raw materials of the test food (soybean and gelatin), or possible to have serious allergic reactions to other foods and/or medicines
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period
10. Subjects who are judged as ineligible to participate in the study by the physician
80
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
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
ORTHOMEDICO Inc.
DHC Corporation
Profit organization
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@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)
2018 | Year | 09 | Month | 28 | Day |
Unpublished
88
Completed
2018 | Year | 09 | Month | 25 | Day |
2018 | Year | 09 | Month | 25 | Day |
2018 | Year | 09 | Month | 29 | Day |
2019 | Year | 04 | Month | 27 | Day |
2018 | Year | 09 | Month | 28 | Day |
2020 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039120
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