Phytosterol Supplementation and Cardiovascular Risk

NCT ID: NCT00153738

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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phytosterol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cargill

INDUSTRY

Sponsor Role collaborator

The Cooper Institute

OTHER

Sponsor Role lead

Principal Investigators

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Conrad Earnest, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Institute

Locations

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The Cooper Institute

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CI0129

Identifier Type: -

Identifier Source: org_study_id

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