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Completed

NCT Number: NCT02065180

The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Antwerp

Antwerp, Belgie, 2610, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • metabolic syndrome according to ATPIII criteria 3 of the following:
  • waist circumference >88cm (in females) or >102cm (in males)
  • triglycerides >150mg/dl
  • HDL <40 (50)mg/dl in males (females)
  • blood pressure>130/85 or treatment for AHT
  • glucose >110mg/dl

Exclusion criteria

  • pregnancy
  • treatment with cholesterol lowering drugs

Treatment and study plan

commercially available nutrition supplement

Dietary Supplement

the food supplement contains red rice yeast and olive extract

Placebo

Dietary Supplement

Primary outcomes

  1. LDL level

    Time frame: 2 months

  2. total cholesterol level

    Time frame: 2 months

  3. triglyceride level

    Time frame: 2 months

  4. HDL level

    Time frame: 2 months

Secondary outcomes

  1. OxLDL

    Time frame: 2 months

  2. BMI

    Time frame: 2 months

  3. malondialdehyde (MDA)

    Time frame: 2 months

  4. 8-OH-deoxyguanosine (8-OHdG)

    Time frame: 2 months

  5. side effects

    Time frame: 2 months

  6. waist circumference

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Official study title

The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2014
Registry last updated
May 20, 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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