Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk

Hypercholesterolemia Clinical Trial

— BOLD  

Official title:

BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937898
• Other study ID #: PKE101
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: March 2012

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. BMI > 20 and < 37

2. 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)

3. TG level < 150 mg/dL

Exclusion criteria include:

1. self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)

2. high alcohol consumption (= 14 drinks/week)

3. intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)

4. treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications

5. vegetarian diet

6. weight loss or gain = 10% body weight in the previous 6 months,

7. lactation, pregnancy, or desire to become pregnant during the study

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia
• Hypertriglyceridemia

Intervention

Dietary Supplement:
• BOLD+ Diet
Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors
• BOLD diet
Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Cattlemen's Beef Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipids (Total cholesterol, LDL-C, HDL-C, TG)		End of each 5 week diet period (weeks 5, 11, 17, 23)
Secondary	Apolipoprotein levels		End of each 5 week diet period (weeks 5, 11, 17, 23)
Secondary	Vascular function		End of each 5 week diet period (weeks 5, 11, 17, 23)
Secondary	Oxidative Stress		End of each 5 week diet period (weeks 5, 11, 17, 23)