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Completed

NCT Number: NCT02628990

Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.6 g plant stanols

Other

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols

2 g plant stanols

Other

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols

1.6 g plant stanols and camelina oil

Other

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil

2 g plant stanols and camelina oil

Other

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil

Placebo

Other

Lipid-lowering effect of Placebo Yoghurt Drink

Primary outcomes

  1. Percentual change in serum LDL-cholesterol

    Time frame: 4 weeks

    Percentual change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups

  2. Absolute change in serum LDL-cholesterol

    Time frame: 4 weeks

    Absolute change [end of intervention - start of intervention] in serum LDL-cholesterol between experimental and placebo groups, mmol/l

Secondary outcomes

  1. Percentual change in serum total cholesterol

    Time frame: 4 weeks

    Percentual change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups

  2. Absolute change in serum total cholesterol

    Time frame: 4 weeks

    Absolute change [end of intervention - start of intervention] in serum total cholesterol between experimental and placebo groups, mmol/l

  3. Percentual change in serum non-HDL cholesterol

    Time frame: 4 weeks

    Percentual change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups

  4. Absolute change in serum non-HDL cholesterol

    Time frame: 4 weeks

    Absolute change [end of intervention - start of intervention] in serum nonHDL cholesterol between experimental and placebo groups, mmol/l

  5. Percentual change in serum triglycerides

    Time frame: 4 weeks

    Percentual change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups

  6. Absolute change in serum triglycerides

    Time frame: 4 weeks

    Absolute change [end of intervention - start of intervention] in serum triglycerides between experimental and placebo groups, mmol/l

Sponsors and collaborators

Lead sponsor

Raisio Group

Industry

Collaborators

  • University of Turku

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Dec 11, 2015
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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