Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism

NCT ID: NCT00860509

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-03-31

Brief 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.

Conditions

Hypercholesterolemia; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Low Phytosterol Diet

Diet with 100 mg of daily phytosterols

Group Type: PLACEBO_COMPARATOR

Low Phytosterol and High Phytosterol Diets

Intervention Type: OTHER

Diets with 600 or 100 mg of daily phytosterols for 4 weeks were given to each subject, in random order

High Phytosterol Diet

Diet with 600 mg of daily phytosterols

Group Type: ACTIVE_COMPARATOR

Low Phytosterol and High Phytosterol Diets

Intervention Type: OTHER

Diets with 600 or 100 mg of daily phytosterols for 4 weeks were given to each subject, in random order

Interventions

Low Phytosterol and High Phytosterol Diets

Diets with 600 or 100 mg of daily phytosterols for 4 weeks were given to each subject, in random order

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female of any race or ethnicity between 18 to 80 years of age, inclusive;
• Body mass index between 20-35 kg/m2;
• LDL-cholesterol between 100-189 mg/dL based on the average of duplicate screening measures. If the two LDL-C levels differ by more than 30 mg/dL, a third test will be scheduled with all three results averaged;
• Free of chronic disease;
• Willing to eat only the foods that are provided by the Center during the diet periods;
• Willing to consume no more than 1 alcoholic drink per day.
• Willing to abstain from the consumption of alcohol for 48-hours prior to blood draw days;
• Willing to drink no more than 5 cups of caffeine-containing beverages a day.

Exclusion Criteria

• Age < 18 or > 80 years;
• Based on duplicate screening laboratory values: 1) LDL-C > or = 190 mg/dL; 2) TG > or = 250 mg/dL; 3) blood pressure > or = 160 mm Hg systolic or 95 mm Hg diastolic;
• Documented presence of atherosclerotic disease;
• Diabetes mellitus;
• Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease;
• Body mass index > 35;
• For women, pregnancy, breast feeding or postpartum < 6 months;
• For women, peri-menopausal;
• History of drug or alcohol abuse;
• History of depression or mental illness requiring treatment or medication within the last 6 months;
• Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
• Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids;
• Lifestyle or schedule incompatible with the study protocol;
• Planned continued use of dietary supplements through the study trial;
• Taking any lipid-lowering, or other medications known to affect blood cholesterol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Washington University School of Medicine

Principal Investigators

Richard Ostlund, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Pennington Biomedical Research Center-Louisana State University System

Baton Rouge, Louisiana, United States

Countries

United States

References

Lin X, Racette SB, Lefevre M, Spearie CA, Most M, Ma L, Ostlund RE Jr. The effects of phytosterols present in natural food matrices on cholesterol metabolism and LDL-cholesterol: a controlled feeding trial. Eur J Clin Nutr. 2010 Dec;64(12):1481-7. doi: 10.1038/ejcn.2010.180. Epub 2010 Sep 1.

Reference Type: RESULT

PMID: 20808333 (View on PubMed)

Other Identifiers

PBRC26030

Identifier Type: -

Identifier Source: org_study_id