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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021975
Receipt No. 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

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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
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 Center of Health Information Science
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 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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025332

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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