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Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

Primary Purpose

Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1.6 g plant stanols
2 g plant stanols
1.6 g plant stanols and camelina oil
2 g plant stanols and camelina oil
Placebo
Sponsored by
Raisio Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI < 30 kg/m2
  • moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
  • serum triglycerides < 3 mmol/l.
  • normal liver, kidney and thyroid function
  • subjects must voluntarily sign the informed consent

Exclusion Criteria:

  • use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
  • lipid lowering medication
  • history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
  • pregnancy or lactation
  • alcohol abuse
  • subjects with intolerance to any ingredient of the test products

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1.6 g plant stanols

    2 g plant stanols

    1.6 g plant stanols and camelina oil

    2 g plant stanols and camelina oil

    Placebo

    Arm Description

    A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks

    A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks

    A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

    A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

    A placebo yoghurt drink, consumed with a meal daily for 4 weeks

    Outcomes

    Primary Outcome Measures

    Percentual change in serum LDL-cholesterol
    Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups
    Absolute change in serum LDL-cholesterol
    Absolute change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups, mmol/l

    Secondary Outcome Measures

    Percentual change in serum total cholesterol
    Percentual change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups
    Absolute change in serum total cholesterol
    Absolute change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups, mmol/l
    Percentual change in serum non-HDL cholesterol
    Percentual change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups
    Absolute change in serum non-HDL cholesterol
    Absolute change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l
    Percentual change in serum triglycerides
    Percentual change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups
    Absolute change in serum triglycerides
    Absolute change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups, mmol/l

    Full Information

    First Posted
    December 1, 2015
    Last Updated
    December 9, 2015
    Sponsor
    Raisio Group
    Collaborators
    University of Turku
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02628990
    Brief Title
    Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks
    Official Title
    The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    November 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Raisio Group
    Collaborators
    University of Turku

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects

    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
    155 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1.6 g plant stanols
    Arm Type
    Experimental
    Arm Description
    A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks
    Arm Title
    2 g plant stanols
    Arm Type
    Experimental
    Arm Description
    A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks
    Arm Title
    1.6 g plant stanols and camelina oil
    Arm Type
    Experimental
    Arm Description
    A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks
    Arm Title
    2 g plant stanols and camelina oil
    Arm Type
    Experimental
    Arm Description
    A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    A placebo yoghurt drink, consumed with a meal daily for 4 weeks
    Intervention Type
    Other
    Intervention Name(s)
    1.6 g plant stanols
    Intervention Description
    Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols
    Intervention Type
    Other
    Intervention Name(s)
    2 g plant stanols
    Intervention Description
    Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols
    Intervention Type
    Other
    Intervention Name(s)
    1.6 g plant stanols and camelina oil
    Intervention Description
    Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil
    Intervention Type
    Other
    Intervention Name(s)
    2 g plant stanols and camelina oil
    Intervention Description
    Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Lipid-lowering effect of Placebo Yoghurt Drink
    Primary Outcome Measure Information:
    Title
    Percentual change in serum LDL-cholesterol
    Description
    Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups
    Time Frame
    4 weeks
    Title
    Absolute change in serum LDL-cholesterol
    Description
    Absolute change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups, mmol/l
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Percentual change in serum total cholesterol
    Description
    Percentual change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups
    Time Frame
    4 weeks
    Title
    Absolute change in serum total cholesterol
    Description
    Absolute change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups, mmol/l
    Time Frame
    4 weeks
    Title
    Percentual change in serum non-HDL cholesterol
    Description
    Percentual change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups
    Time Frame
    4 weeks
    Title
    Absolute change in serum non-HDL cholesterol
    Description
    Absolute change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l
    Time Frame
    4 weeks
    Title
    Percentual change in serum triglycerides
    Description
    Percentual change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups
    Time Frame
    4 weeks
    Title
    Absolute change in serum triglycerides
    Description
    Absolute change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups, mmol/l
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI < 30 kg/m2 moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l) serum triglycerides < 3 mmol/l. normal liver, kidney and thyroid function subjects must voluntarily sign the informed consent Exclusion Criteria: use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention lipid lowering medication history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases pregnancy or lactation alcohol abuse subjects with intolerance to any ingredient of the test products

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26998355
    Citation
    Salo P, Kuusisto P. Cholesterol Lowering Effect of Plant Stanol Ester Yoghurt Drinks with Added Camelina Oil. Cholesterol. 2016;2016:5349389. doi: 10.1155/2016/5349389. Epub 2016 Feb 21.
    Results Reference
    derived

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    Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

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