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

Not Applicable

Completed

• Conditions: Hypertriglyceridemia; Hypercholesterolemia
• Interventions: Dietary Supplement: BOLD+ Diet; Dietary Supplement: BOLD diet

• Registration Number: NCT00937898
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2011-08
• Study Completion: 2012-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Average American Diet	BOLD+ Diet	Typical American diet (16% protein, \~50% carbohydrate, 33% fat)
DASH Diet	BOLD+ Diet	High fruit and vegetable, low sodium diet
DASH Diet	BOLD diet	High fruit and vegetable, low sodium diet
Average American Diet	BOLD diet	Typical American diet (16% protein, \~50% carbohydrate, 33% fat)

Primary Outcome Measures

Name	Time	Method
Lipids (Total cholesterol, LDL-C, HDL-C, TG)	End of each 5 week diet period (weeks 5, 11, 17, 23)

Secondary Outcome Measures

Name	Time	Method
Apolipoprotein levels	End of each 5 week diet period (weeks 5, 11, 17, 23)
Vascular function	End of each 5 week diet period (weeks 5, 11, 17, 23)
Oxidative Stress	End of each 5 week diet period (weeks 5, 11, 17, 23)