Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

January 7, 2015 updated by: Raisio Group

Serum Cholesterol Reduction Efficacy of Biscuit With Added Plant Stanol Ester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Nakhon Pathom
      • Phutthamonthon, Nakhon Pathom, Thailand, 73170
        • Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo biscuit
Biscuit without plant stanol ester
Dietary supplement: Placebo
Experimental: Plant stanol ester biscuit
Biscuit with plant stanol esters
Dietary supplement: Plant stanol ester

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raisio Group

Collaborators

Mahidol University

Investigators

  • Principal Investigator: Wantanee Kriengsinyos, PhD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

December 31, 2014

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL 2012_034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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