Status:
COMPLETED
Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk
Lead Sponsor:
Penn State University
Collaborating Sponsors:
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Conditions:
Hypercholesterolemia
Hypertriglyceridemia
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- BMI \> 20 and \< 37
- LDL-C level between the 50th and 90th percentile (±5% for assay variation) according to NHANES data for sex and age (ex. for men: 128-177 mg/dL and for women: 121-172 mg/dL)
- TG level \< 150 mg/dL
- Exclusion criteria include:
- self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
- high alcohol consumption (≥ 14 drinks/week)
- intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
- treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications
- vegetarian diet
- weight loss or gain ≥ 10% body weight in the previous 6 months,
- lactation, pregnancy, or desire to become pregnant during the study
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00937898
Start Date
August 1 2007
End Date
March 1 2012
Last Update
August 21 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.