Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of the Tea Containing Enzymatically Modified Rutin on Lipid Metabolism Improvement

Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of the Tea Containing Enzymatically Modified Rutin on Lipid Metabolism Improvement - The Effect of Daily Ingestion of the Tea Containing Enzymatically Modified Rutin on Lipid Metabolism Improvement

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017204

Enrollment

Registered

2015-04-21

Start date

2015-04-27

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 the rutin tea containing 500mg enzymatically modified rutin daily for 12 weeks Ingestion of the rutin tea containing 200mg enzymatically modified rutin daily for 12 weeks Ingestion of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects whose LDL-Cho is between 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, diabetes and/or hypertension 2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities 3.Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4. Subjects with unusually high and/or low blood pressure or abnormal hematological data 5. Subjects with serious anemia 6. Pre- or post-menopausal subjects having complaints of obvious physical changes 7. Subjects who are at risk of having allergic reactions to drugs or foods (especially tea) 8. Subjects regularly take medicine , functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, and/or dietary fiber, etc.) which would affect the blood lipids. 9. Subjects regularly take medicine functional foods and/or supplements based on dietary fiber from resistant dextrin, and/or polyphenols, etc. which would affect the blood glucose. 10. Subjects regularly take medicine, functional foods and/or supplements ( peptide, acetic acid, GABA, geniposidic acid, flavonoids, sesamin, chlorella, olive leaves, garlics, dietary fiber, tomatoes, folic acid, etc.) which would affect the blood pressure. 11. Heavy smokers, alcohol addicts or subjects with irregular lifestyle 12. 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. 13. Subjects who are pregnant or expected to be pregnant, or lactating during the study 14. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial 15. Any other medical reasons judged by the the principal investigator

Design outcomes

Primary

Measure	Time frame
LDL-Cho	—

Secondary

Measure	Time frame
T-Cho, HDL-Cho, TG, NEFA, phospholipid, fasting blood glucose, HbA1c, glycoalbumin, pentosidine oxo-LDL, TBARS, blood-pressure	—

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