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Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

Primary Purpose

Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Plant stanol ester

Placebo

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

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

Inclusion Criteria:

Serum total cholesterol 5.2-8.5 mmol/l
Serum triglycerides < 3 mmol/l
Signed written informed consent

Exclusion Criteria:

Abnormal liver, kidney and thyroid function
Use of lipid lowering medication
Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
Diagnosed type 1 or type 2 diabetes requiring medical treatment
History of recent temporal ischemic attack or malignant diseases (< 5 yrs)
Celiac disease, or allergy or intolerance to the ingredients of the test products
Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
Subjects with alcohol abuse (> 4 portion per day)
Pregnancy or planned pregnancy or lactating

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Plant stanol ester

Placebo

Arm Description

Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).

Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).

Outcomes

Primary Outcome Measures

Percentage change in serum LDL cholesterol

Secondary Outcome Measures

Absolute change in serum LDL cholesterol (mmol/l)

Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides

Full Information

NCT ID

NCT03284918

First Posted

September 13, 2017

Last Updated

September 13, 2017

Sponsor

Raisio Group

Collaborators

Medfiles Ltd., Finland

1. Study Identification

Unique Protocol Identification Number

NCT03284918

Brief Title

Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

Official Title

Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Raisio Group

Collaborators

Medfiles Ltd., Finland

4. Oversight

5. Study Description

Brief Summary

The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.

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

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plant stanol ester

Arm Type

Experimental

Arm Description

Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).

Intervention Type

Dietary Supplement

Intervention Name(s)

Plant stanol ester

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Percentage change in serum LDL cholesterol

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Absolute change in serum LDL cholesterol (mmol/l)

Time Frame

4 weeks

Title

Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Serum total cholesterol 5.2-8.5 mmol/l Serum triglycerides < 3 mmol/l Signed written informed consent Exclusion Criteria: Abnormal liver, kidney and thyroid function Use of lipid lowering medication Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2 History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months Diagnosed type 1 or type 2 diabetes requiring medical treatment History of recent temporal ischemic attack or malignant diseases (< 5 yrs) Celiac disease, or allergy or intolerance to the ingredients of the test products Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet Subjects with alcohol abuse (> 4 portion per day) Pregnancy or planned pregnancy or lactating

12. IPD Sharing Statement

Citations:

PubMed Identifier

29854447

Citation

Sarkkinen E, Lyyra M, Nieminen S, Kuusisto P, Wester I. Cereal-Based Snack Bar with Added Plant Stanol Ester (Benecol(R)) Consumed between Meals Lowers Serum Total and LDL Cholesterol Effectively in Mildly to Moderately Hypercholesterolemic Subjects. Cholesterol. 2018 May 2;2018:1463628. doi: 10.1155/2018/1463628. eCollection 2018.

Results Reference

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Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

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