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Completed

NCT Number: NCT00153738

Phytosterol Supplementation and Cardiovascular Risk

This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.

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Key information

Conditions

Hypercholesteremia 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

Primary location

The Cooper Institute

Dallas, Texas, 75230, United States

About this study

This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.

The study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (>130 mg/dl LDL-C). They were assigned to 1 of 2 groups. Participants ingested the supplement or a placebo for 12 weeks, with an interim assessment at 6 weeks. Participants agreed to maintain current diet, medication, and exercise habits and to not donate blood during the trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and exercise habits

Exclusion criteria

  • BMI <18.5 or >34.9, recent blood donation, serious or life-threatening disease

Treatment and study plan

phytosterol

Drug

Primary outcomes

  1. Ingestion of the supplement will result in reduced LDL cholesterol.

Sponsors and collaborators

Lead sponsor

The Cooper Institute

Other

Collaborators

  • Cargill

Registry information

Official study title

Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk

Important dates

Study start
2004
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Mar 13, 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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