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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

A Double-Blind, Placebo-Controlled Study for Effects of Daily Ingestion of Azuki (Vigna angularis) bean Polyphenol on Lipid Metabolism Improvement - The effects of daily ingestion of Azuki bean polyphenol on lipid metabolism improvement.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021975
Enrollment
40
Registered
2016-04-20
Start date
2016-04-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Ingestion of 430mg Azuki polyphenol daily for 8 weeks. Ingestion of dextrin daily for 8 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
LDL-Cho at 4weeks and 8 weeks after the beginning of daily ingestion of test meals.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Hokkaido Information University Center of Health Information Science

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026