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Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Primary Purpose

Dyslipidemias, Hypercholesterolemia, Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
Thailand
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 - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
  • fasting serum triglyceride levels below 3.0 mmol/l
  • normal liver, kidney and thyroid function
  • no lipid lowering medication
  • no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases

Exclusion Criteria:

  • alcohol abuse (> 4 portion/per day)
  • pregnancy
  • use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included

Sites / Locations

  • Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo biscuit

Plant stanol ester biscuit

Arm Description

Biscuit without plant stanol ester

Biscuit with plant stanol esters

Outcomes

Primary Outcome Measures

Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls

Secondary Outcome Measures

Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal

Full Information

First Posted
December 31, 2014
Last Updated
January 7, 2015
Sponsor
Raisio Group
Collaborators
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02331043
Brief Title
Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester
Official Title
Serum Cholesterol Reduction Efficacy of Biscuit With Added Plant Stanol Ester
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Raisio Group
Collaborators
Mahidol 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 in a biscuit (providing 2 g plant stanols as esters per day) 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 ProviderInvestigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo biscuit
Arm Type
Placebo Comparator
Arm Description
Biscuit without plant stanol ester
Arm Title
Plant stanol ester biscuit
Arm Type
Experimental
Arm Description
Biscuit with plant stanol esters
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant stanol ester
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l) fasting serum triglyceride levels below 3.0 mmol/l normal liver, kidney and thyroid function no lipid lowering medication no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases Exclusion Criteria: alcohol abuse (> 4 portion/per day) pregnancy use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wantanee Kriengsinyos, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)
City
Phutthamonthon
State/Province
Nakhon Pathom
ZIP/Postal Code
73170
Country
Thailand

12. IPD Sharing Statement

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Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

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