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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00937898

Acronym

BOLD

Enrollment

Registered

2009-07-13

Start date

2007-08-31

Completion date

2012-03-31

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Hypertriglyceridemia

Keywords

lean beef, cholesterol, lipids, diet intervention

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.

Interventions

DIETARY_SUPPLEMENTBOLD+ Diet

Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors

DIETARY_SUPPLEMENTBOLD diet

Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026