Unique ID issued by UMIN | UMIN000014526 |
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Receipt number | R000016892 |
Scientific Title | A randomized controlled trial to investigate whether decrease in visceral adipose tissue in human |
Date of disclosure of the study information | 2014/07/09 |
Last modified on | 2017/01/30 18:31:35 |
A randomized controlled trial to investigate whether decrease in visceral adipose tissue in human
A trial to investigate whether decrease in visceral adipose tissue in human
A randomized controlled trial to investigate whether decrease in visceral adipose tissue in human
A trial to investigate whether decrease in visceral adipose tissue in human
Japan |
Healthy adults
Not applicable |
Others
NO
To investigate the effect of test material intake on decrease in visceral adipose tissue in human
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Computed Tomography
Total abdominal adipose tissue area
Subcutaneous adipose tissue area
Visceral adipose tissue area
subjective symptom
Likert scales
blood chemical analysis
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
Free fatty acid
Body analysis
Weight
BMI
Percent body fat
waist circumference
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Food |
Duration: 12 weeks
Test material: PROTON GRAN PRO
shape and size capsule (standard: size 2)
take two capusles twice daily both before breakfast and going to bed during fasting
Duration: 12 weeks
Test material: placebo
shape and size capsule (standard: size 2)
take two capusles twice daily both before breakfast and going to bed during fasting
30 | years-old | <= |
49 | years-old | >= |
Male and Female
a) Persons whose ages are ranging from 30 to 49 years old
b) Persons whose BMIs are 25 or larger
c) Persons who stop intaking other supplements during the test if he/she intakes supplement and nutrient enrichment food habitually
d) Persons who had alcohol drinking less than twice a week
e) Persons who sport less than twice a week
a) Persons who have previous medical history of malignancy, heart failure or myocardial infarction
b) Patients being treated for at least one of following diseases; atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease
c) Persons who take medicines, herbal medicines
d) Persons who are allergic to medicines, or foods related to the test material of this trial
e) Persons who take medicines in relation to pollinosis during the trial period
f) Pregnant women, lactating women, or women who want to get pregnant during the trial period
g) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
h) Persons who are to work or activities in the night
i) Persons who are judged not suitable to participate in this trial by physician.
14
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Esthe Pro Labo Co., Ltd.
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
メディカルスキャニング (東京都)
MEDICAL SCANNING (Tokyo)
2014 | Year | 07 | Month | 09 | Day |
Unpublished
Completed
2014 | Year | 06 | Month | 20 | Day |
2014 | Year | 07 | Month | 10 | Day |
2014 | Year | 11 | Month | 30 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 07 | Month | 09 | Day |
2017 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016892
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