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Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT00937898•Penn State University

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

Age

21 - 65 years

Sex

ALL

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

•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

Key Dates

Start Date

August 1, 2007

Primary Completion Date

August 1, 2011

Completion Date

March 1, 2012

Last Updated

August 21, 2023

Enrollment

ACTUAL participants

Conditions

HypercholesterolemiaHypertriglyceridemia

Interventions

BOLD+ Diet

DIETARY_SUPPLEMENT

BOLD diet

DIETARY_SUPPLEMENT

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077

Heterozygous Familial Hypercholesterolemia (HeFH)

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RECRUITINGNA

Screening for Familial Hypercholesterolemia in Children

NCT06555120

Hypercholesterolemia, Familial

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RECRUITING

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Screening for Familial Hypercholesterolemia in Children

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Causes and Natural History of Dyslipidemias

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Pharmacokinetics of Butyrate Tablet BKR-017