Unique ID issued by UMIN | UMIN000022690 |
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Receipt number | R000026153 |
Scientific Title | The effects of test food(HB-h008) on body fat in healthy Japanese adults: a randomized, placebo-controlled, double-blind trial |
Date of disclosure of the study information | 2016/06/12 |
Last modified on | 2017/02/14 18:11:35 |
The effects of test food(HB-h008) on body fat in healthy Japanese adults: a randomized, placebo-controlled, double-blind trial
The effects of test food(HB-h008) on body fat in healthy Japanese adults
The effects of test food(HB-h008) on body fat in healthy Japanese adults: a randomized, placebo-controlled, double-blind trial
The effects of test food(HB-h008) on body fat in healthy Japanese adults
Japan |
healthy humans
Adult |
Others
NO
To investigate the effect of test food(HB-h008) on body fat area in healthy adults
Efficacy
Body fat area(Visceral fat area, Subcutaneous fat area, Total fat area)
Measuring: at 0 week, 6 weeks and 12 weeks after ingestion
Weight, BMI, Waist circumference, Hip circumference, Blood glucose, Insulin, Glycoalbumin
Measuring: at 0 week, 6 weeks and 12 weeks after ingestion
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Oral ingestion of the placebo control food once daily for 12 weeks
Oral ingestion of the test food(HB-h008) once daily for 12 weeks
20 | years-old | <= |
60 | years-old | > |
Male and Female
(1) 20<=Age<60 of healty men and women
(2) 23<=BMI<30
(1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases
(2) Subjects who indicate disorder of heart and lung function
(3) Subjects who indicate abnormal parameter in liver or kidney function
(4) Subjects who had a gastrointestinal surgery
(5) Subjects with a disease under treatment now
(6) Subjects with drug or food allergy
(7) Subjects who play high intensity sports or are on a diet
(8) Subjects who have a weight change: 2 kg or more when comparing to 1 month prior to the start of the trial
(9) Subjects who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods
(10) Subject who consume exscessive alcohol
(11) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(12) Subjects who is participating in the other study or plannning to participate during the study period
(13) Subjects who isdeemed unsuitable by the principal investigator
100
1st name | |
Middle name | |
Last name | Naoki Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal medicine
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
06-6135-5200
info@miura-cl.jp
1st name | |
Middle name | |
Last name | Makoto Terashima |
Oneness support Co., Ltd.
Clinical trial Division
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
06-4801-8917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
Hayashibara Co., LTD.
Profit organization
NO
医療法人花音会みうらクリニック(大阪府) Miura Clinic, Medical Corporation Kanonkai(Osaka)
2016 | Year | 06 | Month | 12 | Day |
Unpublished
Completed
2016 | Year | 04 | Month | 26 | Day |
2016 | Year | 06 | Month | 14 | Day |
2016 | Year | 06 | Month | 10 | Day |
2017 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026153
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