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

NCT00860509 | Completed

• 1 other identifier: PBRC26030
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

phytosterols; cholesterol excretion; cholesterol absorption; diet; mass spectrometry; deuterium

Outcome Measures

Primary Outcomes (1)

• Fecal cholesterol excretion

  At the end of week 4 on each diet

Secondary Outcomes (1)

• Intestinal cholesterol absorption

  At the end of week 4 on each diet

Study Arms (2)

Low Phytosterol Diet

PLACEBO COMPARATOR

Diet with 100 mg of daily phytosterols

Other: Low Phytosterol and High Phytosterol Diets

High Phytosterol Diet

ACTIVE COMPARATOR

Diet with 600 mg of daily phytosterols

Other: Low Phytosterol and High Phytosterol Diets

Interventions

Low Phytosterol and High Phytosterol Diets OTHER

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

High Phytosterol Diet; Low Phytosterol Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Pennington Biomedical Research Center: collaborator

Study Sites (1)

Pennington Biomedical Research Center-Louisana State University System

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• 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.

  PMID: 20808333 RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Disease

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Richard Ostlund, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: November 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

US (1)