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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284918
• Other study ID #: MFRA004
• Status: Completed
• Phase: N/A
• First received: September 13, 2017
• Last updated: September 13, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2017
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Plant stanol ester

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Raisio Group	Medfiles Ltd., Finland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in serum LDL cholesterol		4 weeks
Secondary	Absolute change in serum LDL cholesterol (mmol/l)		4 weeks
Secondary	Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides		4 weeks