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A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function

A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function - A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046345
Enrollment
72
Registered
2021-12-10
Start date
2021-12-12
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 volunteers

Interventions

Intake of test food for 12 weeks Intake of placebo for 12 weeks

Sponsors

Soiken Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females whose age of 20 years or more and less than 65 years 2) Subjects whose blood LDL cholesterol levels are 120 mg/dL or more and less than 160 mg/dL 3) Subjects whose blood HDL cholesterol levels are 40 mg/dL or more 4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects receiving a medical treatment for chronic diseases (dyslipidemia, high blood pressure, diabetes, etc.) 2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3) Subjects who have the possibility of developing allergic symptoms by the test food 4) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the effects on lipid metabolism (reducing blood LDL cholesterol, triglycerides, etc.) 5) Subjects who take foods having the effects on lipid metabolism (reducing blood LDL cholesterol, triglycerides, etc.) 6) Subjects who have a smoking habit 7) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 8) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 9) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 10) Subjects deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
Blood analysis: LDL cholesterol

Secondary

MeasureTime frame
Blood analysis: HDL cholesterol, total cholesterol, Triglycerides, hsCRP, apolipoprotein A1, apolipoprotein A2, HPLC lipoprotein fraction Vascular endothelial function: %FMD

Countries

Japan

Contacts

Public ContactTomohiro Sugino

Soiken Inc. R&D Division

sugino@soiken.com06-6871-8888

Outcome results

None listed

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