Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

NCT ID: NCT02221297

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-11-30

Brief Summary

Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Supplement product with plant stanol ester

Group Type: EXPERIMENTAL

Supplement product with plant stanol ester

Intervention Type: DIETARY_SUPPLEMENT

2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

Placebo supplement product

Group Type: PLACEBO_COMPARATOR

Supplement product with plant stanol ester

Intervention Type: DIETARY_SUPPLEMENT

2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

Interventions

Supplement product with plant stanol ester

2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• male and female over 18 years old
• serum LDL cholesterol > 3.0 mmol/L
• BMI < 35
• subjects must voluntarily sign the informed consent

Exclusion Criteria

• subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
• subjects with any hepatic or renal disorder according to medical history
• subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
• subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
• subjects who have history of temporal ischemic attack or stroke within six months prior to screening
• subjects who have a history of cancer or other malignant disease within the past five years
• subjects who are consuming more than 15 portions of alcohol / week
• subjects who are pregnant or lactating
• subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
• subjects with intolerance to any ingredient of the test product

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Research Institute HUCH Ltd

OTHER

Sponsor Role: collaborator

Raisio Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CL2014_035

Identifier Type: -

Identifier Source: org_study_id