Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cooper Institute
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Ingestion of the supplement will result in reduced LDL cholesterol.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Single
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Ingestion of the supplement will result in reduced LDL cholesterol.
Secondary Outcomes
No secondary outcomes reported