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OpenTrials
Completed

NCT Number: NCT02331043

Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)

Phutthamonthon, Changwat Nakhon Pathom, 73170, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
  • fasting serum triglyceride levels below 3.0 mmol/l
  • normal liver, kidney and thyroid function
  • no lipid lowering medication
  • no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases

Exclusion criteria

  • alcohol abuse (> 4 portion/per day)
  • pregnancy
  • use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included

Treatment and study plan

Plant stanol ester

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls

    Time frame: 4 weeks

Secondary outcomes

  1. Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Raisio Group

Industry

Collaborators

  • Mahidol University

Registry information

Official study title

Serum Cholesterol Reduction Efficacy of Biscuit With Added Plant Stanol Ester

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 5, 2015
Registry last updated
Jan 8, 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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