Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

Raisio Group

Status: Completed

Conditions: Hyperlipidemias; Dyslipidemias; Hypercholesterolemia

Treatments: Other: 1.6 g plant stanols; Other: 2 g plant stanols and camelina oil; Other: 2 g plant stanols; Other: Placebo; Other: 1.6 g plant stanols and camelina oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02628990

YD2005

Details and patient eligibility

About

The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects

Enrollment: 155 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI < 30 kg/m2
• moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
• serum triglycerides < 3 mmol/l.
• normal liver, kidney and thyroid function
• subjects must voluntarily sign the informed consent

Exclusion criteria

• use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
• lipid lowering medication
• history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
• pregnancy or lactation
• alcohol abuse
• subjects with intolerance to any ingredient of the test products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 5 patient groups, including a placebo group

1.6 g plant stanols

Experimental group

Description:

A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks

Treatment:

Other: 1.6 g plant stanols

2 g plant stanols

Experimental group

Description:

A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks

Treatment:

Other: 2 g plant stanols

1.6 g plant stanols and camelina oil

Experimental group

Description:

A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

Treatment:

Other: 1.6 g plant stanols and camelina oil

2 g plant stanols and camelina oil

Experimental group

Description:

A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

Treatment:

Other: 2 g plant stanols and camelina oil

Placebo

Placebo Comparator group

Description:

A placebo yoghurt drink, consumed with a meal daily for 4 weeks

Treatment:

Other: Placebo