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OpenTrials
Completed

NCT Number: NCT02316808

Cholesterol-lowering Effects of Plant Stanol Ester

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie 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–70 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

  • total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL
  • were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
  • reachable by phone
  • willing to declare written informed consent
  • agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.

Exclusion criteria

  • Pregnant women
  • obese
  • diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL
  • hyperthyroidism, a history of metabolic, endocrine and kidney disorders
  • acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
  • taking lipid-lowering medication or other medications likely to affect lipid metabolism

Treatment and study plan

Plant stanol ester

Dietary Supplement

Smoothie that contains plant stanol ester

Placebo

Dietary Supplement

Smoothie that contains placebo

Primary outcomes

  1. Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Raisio Group

Industry

Collaborators

  • Indonesia University

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2014
Registry last updated
Dec 23, 2014

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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