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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03284918

Enrollment

Registered

2017-09-15

Start date

2016-01-31

Completion date

2016-09-30

Last updated

2017-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Hypercholesterolemia, Hyperlipidemias

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.

Interventions

DIETARY_SUPPLEMENTPlant stanol ester

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage change in serum LDL cholesterol	4 weeks

Secondary

Measure	Time frame
Absolute change in serum LDL cholesterol (mmol/l)	4 weeks
Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides	4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026