Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

Hypercholesterolemia Clinical Trial

Official title:

The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628990
• Other study ID #: YD2005
• Status: Completed
• Phase: N/A
• First received: December 1, 2015
• Last updated: December 9, 2015
• Start date: June 2005
• Est. completion date: November 2005

Study information

• Verified date: December 2015
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: November 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias

Intervention

Other:
• 1.6 g plant stanols
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols
• 2 g plant stanols
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols
• 1.6 g plant stanols and camelina oil
Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil
• 2 g plant stanols and camelina oil
Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil
• Placebo
Lipid-lowering effect of Placebo Yoghurt Drink

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Raisio Group	University of Turku

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentual change in serum LDL-cholesterol	Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups	4 weeks	No
Primary	Absolute change in serum LDL-cholesterol	Absolute change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups, mmol/l	4 weeks	No
Secondary	Percentual change in serum total cholesterol	Percentual change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups	4 weeks	No
Secondary	Absolute change in serum total cholesterol	Absolute change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups, mmol/l	4 weeks	No
Secondary	Percentual change in serum non-HDL cholesterol	Percentual change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups	4 weeks	No
Secondary	Absolute change in serum non-HDL cholesterol	Absolute change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l	4 weeks	No
Secondary	Percentual change in serum triglycerides	Percentual change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups	4 weeks	No
Secondary	Absolute change in serum triglycerides	Absolute change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups, mmol/l	4 weeks	No