UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety Evaluation for Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract.
Title of the study (Brief title)	Safety of Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the food safety of nanoparticulated brown rice germ extract containing 3 times high amount of recommended for 4 weeks daily.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The pattern, severity and frequency of adverse effects related to ingestion of the active test food during the ingestion period and the post ingestion period.
Key secondary outcomes	The pattern, severity and frequency of adverse events during the ingestion period and the post ingestion period. BW, BFP, BMI, BP measured at the hospital, heart rate, hematological test (WBC, RBC, Hb, Ht, and Plt), WBC differential count, biochemical test (AST, ALT, gamma-GTP, ALP, LDH, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, total phospholipids, fasting blood glucose, HbA1c, glycoalbumin, insulin, HOMA-IR, serum total protein, albumin, total bilirubin, A/G ratio, CPK, serum amylase, Na, Cl, K, Ca, P, Fe, Mg, UIBC and TIBC) and urine analysis (pH, protein, sugar, urobilinogen, bilirubin, ketone bodies and occult blood) after 2 and 4 weeks of ingestion and 2 weeks after the end of ingestion.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of 3 tablets of nanoparticulated brown rice germ extract daily for 12 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Subjects who meet the following criterion a, b or c. a.Subjects whose BMI is normal range and TG is normal range. b.Subjects whose BMI is >=23.0 kg/m2 and <30.0 kg/m2. c.Subjects whose TG is >=120 mg/dl and <150 mg/dl. 2.Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria	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.Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 6.Subjects with severe anemia. 7.Pre- or post-menopausal women complaining obvious physical changes. 8.Subjects who are at risk of having allergic reactions to drugs or foods, especially gramineae. 9.Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFP. 10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 11.Subjects who regularly take medicine, functional foods and/or supplements which would affect glucose metabolism. 12.Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle. 13.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. 14.Pregnant or lactating women or women expect to be pregnant during this study. 15.Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 16.Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	SENTAN Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 30 Day
Anticipated trial start date	2017 Year 12 Month 20 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry	2018 Year 03 Month 14 Day
Date trial data considered complete	2018 Year 03 Month 15 Day
Date analysis concluded	2018 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 08 Day
Last modified on	2018 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034628