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Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Primary Purpose

Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supplement product with plant stanol ester
Sponsored by
Raisio Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Supplement product with plant stanol ester

    Placebo supplement product

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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)
    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)

    Full Information

    First Posted
    August 19, 2014
    Last Updated
    October 28, 2015
    Sponsor
    Raisio Group
    Collaborators
    Clinical Research Institute HUCH Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02221297
    Brief Title
    Lipid-lowering Effect of a Plant Stanol Ester Supplement Product
    Official Title
    Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Raisio Group
    Collaborators
    Clinical Research Institute HUCH Ltd

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    103 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supplement product with plant stanol ester
    Arm Type
    Experimental
    Arm Title
    Placebo supplement product
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Supplement product with plant stanol ester
    Intervention Description
    2 grams plant stanols consumed with a meal daily for 3 to 4 weeks
    Primary Outcome Measure Information:
    Title
    Proportional change in serum LDL cholesterol
    Description
    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.
    Time Frame
    3 to 4 weeks
    Secondary Outcome Measure Information:
    Title
    Proportional change in total cholesterol
    Description
    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.
    Time Frame
    3 to 4 weeks
    Title
    Proportional change in non-HDL-cholesterol
    Description
    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.
    Time Frame
    3 to 4 weeks
    Title
    Proportional change in serum triglycerides
    Description
    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.
    Time Frame
    3 to 4 weeks
    Title
    Proportional change in lipids in all study participants
    Description
    Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis)
    Time Frame
    3 to 4 weeks
    Title
    Proportional change in lipids in subjects without metabolic derangements
    Description
    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)
    Time Frame
    3 to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

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