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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030323
Receipt No. R000034628
Scientific Title Safety Evaluation for Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract.
Date of disclosure of the study information 2017/12/08
Last modified on 2018/07/20

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Basic information
Public title Safety Evaluation for Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract.
Acronym Safety of Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract.
Scientific Title Safety Evaluation for Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract.
Scientific Title:Acronym 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
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
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
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 10 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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