UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021975 |
|---|---|
| Receipt number | R000025332 |
| Scientific Title | A Double-Blind, Placebo-Controlled Study for Effects of Daily Ingestion of Azuki (Vigna angularis) bean Polyphenol on Lipid Metabolism Improvement |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2018/10/24 15:04:49 |
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Basic information
Public title
A Double-Blind, Placebo-Controlled Study for Effects of Daily Ingestion of Azuki (Vigna angularis) bean Polyphenol on Lipid Metabolism Improvement
Acronym
The effects of daily ingestion of Azuki bean polyphenol on lipid metabolism improvement.
Scientific Title
A Double-Blind, Placebo-Controlled Study for Effects of Daily Ingestion of Azuki (Vigna angularis) bean Polyphenol on Lipid Metabolism Improvement
Scientific Title:Acronym
The effects of daily ingestion of Azuki bean polyphenol on lipid metabolism improvement.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove clinical benefits associated with ingestion of azuki polyphenol daily for 8 weeks on lipid metabolism. Additionally to examine anti-oxidant effects in order to evaluate the comprehensive effects of azuki polyphenol for health promotion and health maintenance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
LDL-Cho at 4weeks and 8 weeks after the beginning of daily ingestion of test meals.
Key secondary outcomes
Blood lipid (TC, HDL-Cho, TG, Arteriosclerotic index), Blood glucose (fasting blood glucose, HbA1c), Oxidative lipid marker (oxo-LDL, TBARS), Adiponectin, Blood pressure, Body composition (BW, BFP, BMI).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 430mg Azuki polyphenol daily for 8 weeks.
Interventions/Control_2
Ingestion of dextrin daily for 8 weeks.
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects whose LDL-Cho is >=120mg/dl and < 180mg/dl
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1. Subjects who are under treatment and medication for hyperlipidemia.
2. Subjects who are determined to familial hypercholesterolemia.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities.
4. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects with unusually high and/or low blood pressure or abnormal hematological data.
6. Subjects with serious anemia.
7. Pre- or post-menopausal women having obvious changes in physical condition.
8. Subjects who are at risk of having allergic reactions to drugs or foods (especially Azuki bean, pork, gelatin, and soybean).
9. Subjects who regularly take drugs, functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols and dietary fiber such as indigestible dextrin, etc.) which would affect the blood lipid levels.
10. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
11. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
12. Pregnant or lactating women or women expect to be pregnant during the clinical trial.
13. Subjects who participate in other clinical trials within the last one month prior to this study.
14. Any other medical reasons judged by the principal investigator.
Target sample size
40
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
Center of Health Information Science
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
Cosmo Foods Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 20 | 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
| 2016 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025332
