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Phytosterol Diet

High Phytosterol Diet for High Cholesterol (Phyteaux-II Trial)

N/A
Waitlist Available
Led By Richard Ostlund, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

The objective of this study is to compare cholesterol absorption and metabolism after feeding diets naturally low or high in phytosterols. All meals will be prepared in a metabolic kitchen and analyzed for phytosterols. In a randomized crossover design a group of up to 25 healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols for 4 weeks. At the end of each dietary period percent cholesterol absorption, fecal cholesterol excretion and LDL cholesterol level will be measured. The hypothesis is that LDL cholesterol and cholesterol excretion will be improved on the high phytosterol diet even though macronutrient composition, mineral intake and fiber consumption are similar.

Eligible Conditions
  • High Cholesterol
  • Coronary Heart Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: High Phytosterol DietActive Control1 Intervention
Diet with 600 mg of daily phytosterols
Group II: Low Phytosterol DietPlacebo Group1 Intervention
Diet with 100 mg of daily phytosterols

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,995 Previous Clinical Trials
2,296,873 Total Patients Enrolled
Pennington Biomedical Research CenterOTHER
309 Previous Clinical Trials
180,112 Total Patients Enrolled
Richard Ostlund, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
22 Total Patients Enrolled
~1 spots leftby Nov 2025