Back to resultsPhytosterol Supplementation and Cardiovascular Risk
Primary Purpose
Hypercholesteremia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
phytosterol
Sponsored by
About this trial
This is an interventional prevention trial for Hypercholesteremia focused on measuring LDL-C, phytosterol
Eligibility Criteria
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
Sites / Locations
- The Cooper Institute
Outcomes
Primary Outcome Measures
Ingestion of the supplement will result in reduced LDL cholesterol.
Secondary Outcome Measures
Full Information
NCT ID
NCT00153738
First Posted
September 7, 2005
Last Updated
March 12, 2014
Sponsor
The Cooper Institute
Collaborators
Cargill
1. Study Identification
Unique Protocol Identification Number
NCT00153738
Brief Title
Phytosterol Supplementation and Cardiovascular Risk
Official Title
Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Cooper Institute
Collaborators
Cargill
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia
Keywords
LDL-C, phytosterol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
72 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
phytosterol
Primary Outcome Measure Information:
Title
Ingestion of the supplement will result in reduced LDL cholesterol.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad Earnest, PhD
Organizational Affiliation
The Cooper Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cooper Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
12. IPD Sharing Statement
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Phytosterol Supplementation and Cardiovascular Risk
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