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A Double-Blind, Placebo-Controlled Study for Effects of Daily Ingestion of Azuki (Vigna angularis) bean Polyphenol on Lipid Metabolism Improvement

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	2016/04/19
Target sample size	40
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Ingestion of 430mg Azuki polyphenol daily for 8 weeks. Ingestion of dextrin daily for 8 weeks.

Outcome(s)

Primary Outcome	LDL-Cho at 4weeks and 8 weeks after the beginning of daily ingestion of test meals.
Secondary Outcome	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).

Key inclusion & exclusion criteria

Age minimum	35years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude 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.