Unique ID issued by UMIN | UMIN000029511 |
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Receipt number | R000033721 |
Scientific Title | Dose determination study of Nanoparticulated Brown Rice Germ Extract on Body Fat Reduction by Daily Ingestion. |
Date of disclosure of the study information | 2017/10/13 |
Last modified on | 2018/07/20 12:26:41 |
Dose determination study of Nanoparticulated Brown Rice Germ Extract on Body Fat Reduction by Daily Ingestion.
Effects of Reducing Body Fat by Daily Ingestion of Nanoparticulated Brown Rice Germ Extract.
Dose determination study of Nanoparticulated Brown Rice Germ Extract on Body Fat Reduction by Daily Ingestion.
Effects of Reducing Body Fat by Daily Ingestion of Nanoparticulated Brown Rice Germ Extract.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To prove clinical benefits associated with daily nanoparticulated brown rice germ extract ingestion for 12 weeks on body fat reduction by which the potential health benefits of the brown rice extract is investigated.
Efficacy
Pragmatic
Not applicable
Abdominal visceral fat area after 4, 8 and 12 weeks of ingestion.
body weight, BFP, BMI, waist circumference, TC, LDL-C, HDL-C, TG, LDL-C/HDL-C, non-HDL, fasting blood glucose levels, HbA1c, insulin, HOMA-IR, adiponectin , leptin, Olfactory test and DASC-21.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
6
Treatment
Food |
Ingestion of 2 tablets of nanoparticulated brown rice germ extract (high dose) daily for 12 weeks.
Ingestion of 2 tablets of nanoparticulated brown rice germ extract (medium dose) daily for 12 weeks.
Ingestion of 2 tablets of nanoparticulated brown rice germ extract (low dose) daily for 12 weeks.
Ingestion of 2 tablets of placebo tablet daily for 12 weeks.
Ingestion of 15g of rice bran oil containing nanoparticulated rice germ extract daily for 12 weeks.
Ingestion of 15g of placebo oil (normal rice bran oil) daily for 12 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1.Subjects whose BMI is >=23 kg/m2 and <30 kg/m2.
2.Subjects whose Abdominal visceral fat area is <100cm2.
3.Subjects who agree to participate in this study with a written informed consent.
1.Subjects who are under physician's advice, treatment and/or medication for obese, hyperlipidemia and diabetes.
2.Subjects with familial hypercholesterolemia.
3.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
4.Pacemaker or defibrillator users.
5.Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7.Subjects with severe anemia.
8.Pre- or post-menopausal women complaining obvious physical changes.
9.Subjects who are at risk of having allergic reactions to drugs or foods, especially gramineae.
10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFP.
11.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels.
12.Subjects who regularly take medicine, functional foods and/or supplements which would affect glucose metabolism.
13.Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle.
14.Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study.
15.Pregnant or lactating women or women expect to be pregnant during this study.
16.Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study.
17.Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
120
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
SENTAN Pharma Inc.
Profit organization
Japan
NO
北海道情報大学 保健センター(北海道)
2017 | Year | 10 | Month | 13 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 25 | Day |
2017 | Year | 10 | Month | 18 | Day |
2018 | Year | 02 | Month | 12 | Day |
2018 | Year | 02 | Month | 25 | Day |
2018 | Year | 02 | Month | 26 | Day |
2018 | Year | 05 | Month | 14 | Day |
2017 | Year | 10 | Month | 11 | Day |
2018 | Year | 07 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033721
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