UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030323 |
|---|---|
| Receipt number | 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 12:28:50 |
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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
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
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034628
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