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Cholesterol-lowering Effects of Plant Stanol Ester

Primary Purpose

Dyslipidemias, Hypercholesterolemia, Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plant stanol ester
placebo
Sponsored by
Raisio Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL
  • were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
  • reachable by phone
  • willing to declare written informed consent
  • agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.

Exclusion Criteria:

  • Pregnant women
  • obese
  • diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL
  • hyperthyroidism, a history of metabolic, endocrine and kidney disorders
  • acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
  • taking lipid-lowering medication or other medications likely to affect lipid metabolism

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo smoothie

    Plant stanol ester smoothie

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2014
    Last Updated
    December 19, 2014
    Sponsor
    Raisio Group
    Collaborators
    Indonesia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02316808
    Brief Title
    Cholesterol-lowering Effects of Plant Stanol Ester
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo smoothie
    Arm Type
    Placebo Comparator
    Arm Title
    Plant stanol ester smoothie
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Plant stanol ester
    Intervention Description
    Smoothie that contains plant stanol ester
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    Smoothie that contains placebo
    Primary Outcome Measure Information:
    Title
    Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks, reachable by phone willing to declare written informed consent agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions. Exclusion Criteria: Pregnant women obese diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL hyperthyroidism, a history of metabolic, endocrine and kidney disorders acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV) taking lipid-lowering medication or other medications likely to affect lipid metabolism

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29535869
    Citation
    Lestiani L, Chandra DN, Laitinen K, Ambarwati FD, Kuusisto P, Lukito W. Double-Blind Randomized Placebo Controlled Trial Demonstrating Serum Cholesterol Lowering Efficacy of a Smoothie Drink with Added Plant Stanol Esters in an Indonesian Population. Cholesterol. 2018 Feb 4;2018:4857473. doi: 10.1155/2018/4857473. eCollection 2018.
    Results Reference
    derived

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    Cholesterol-lowering Effects of Plant Stanol Ester

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