Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Hypercholesterolemia Clinical Trial

Official title:

Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221297
• Other study ID #: CL2014_035
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: October 28, 2015
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2015
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Supplement product with plant stanol ester
2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Raisio Group	Clinical Research Institute HUCH Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportional change in serum LDL cholesterol	Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.	3 to 4 weeks	No
Secondary	Proportional change in total cholesterol	Proportional change [end of intervention - start of intervention] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.	3 to 4 weeks	No
Secondary	Proportional change in non-HDL-cholesterol	Proportional change [end of intervention - start of intervention] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.	3 to 4 weeks	No
Secondary	Proportional change in serum triglycerides	Proportional change [end of intervention - start of intervention] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.	3 to 4 weeks	No
Secondary	Proportional change in lipids in all study participants	Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis)	3 to 4 weeks	No
Secondary	Proportional change in lipids in subjects without metabolic derangements	Proportional change [end of intervention - start of intervention] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome)	3 to 4 weeks	No