Phytosterol Supplementation and Cardiovascular Risk

Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00153738

Enrollment

Registered

2005-09-12

Start date

2004-03-31

Completion date

2005-08-31

Last updated

2014-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesteremia

Keywords

LDL-C, phytosterol

Brief summary

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.

Interventions

DRUGphytosterol

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Ingestion of the supplement will result in reduced LDL cholesterol.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026