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Completed

NCT Number: NCT00937638

Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome

The proposed research will provide important information about the role of 2 intervention diets that provide different amounts of lean beef and meet current nutrient recommendations for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain their weight loss, as is currently recommended in clinical practice. Importantly, the investigators will compare a diet high in lean beef (5 oz/day) which is compositionally similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors, including MetSyn. In addition, the investigators also will evaluate a moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study was conducted to assess dietary compliance in a sub-sample of the population at 12-months; participants were not informed of this end-point and additional consent was obtained.

Hypotheses:

1. Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will show similar or greater reductions in CVD risk, respectively when compared to a modified-DASH diet. 2. A healthful weight-loss diet, including lean beef as the primary source of protein in a high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more than a BOLD + ex and DASH + ex intervention. 3. The BOLD diet will be more effective than the modified-DASH diet, and the BOLD+ diet more effective than the BOLD diet in maintaining the CVD benefits attained during phases 1 and 2. Dietary adherence will be better on the BOLD and BOLD + diets compared with the modified DASH diet.

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Key information

Conditions

Metabolic Syndrome Cardiovascular Disease Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (BMI 27-42 kg/m2)
  • Three or more of the following risk factors (defined as having MetSyn):
  • abdominal obesity [waist circumference > 102 cm (40 inches) in men and > 88 cm (35 inches) in women],
  • elevated blood glucose [> 110mg/dl (6.1 mmol/L)]
  • elevated TG [>150 mg/dl (1.7 mmol/L)]
  • low HDL-C [<40 mg/dl (1.03 mmol/L) in men and <50 mg/dL (1.29 mmol/l) in women]
  • hypertension (Systolic Blood Pressure > 130 mmHg or Diastolic Blood Pressure > 85 mmHg)*
  • BP medication accepted if BP stable and less than 160/100mm Hg

Exclusion criteria

  • A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
  • Lactation, pregnancy, or desire to become pregnant during the study
  • Intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
  • High alcohol consumption (≥ 14 drinks/week)
  • Participation in regular physical activity (> 1 formal session/week)
  • Lipid or glucose lowering medication

Treatment and study plan

BOLD diet

Dietary Supplement

Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day)

Other names: Low fat, Step II diet

BOLD-X Diet

Dietary Supplement

Low-fat, moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet. Also high in fruits and vegetables

Other names: Low fat, moderate protein

Modified DASH Diet

Dietary Supplement

Low-fat, high fruit and vegetable diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors and metabolic syndrome

Other names: DASH diet

Primary outcomes

  1. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Time frame: 2 weeks

  2. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Time frame: 7 weeks

  3. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Time frame: 13 weeks

  4. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Time frame: 24 weeks

Secondary outcomes

  1. Vascular endothelial function measured by endo-PAT

    Time frame: 2 weeks

  2. Lipids and lipoproteins

    Time frame: 2 weeks

  3. Inflammatory markers

    Time frame: 2 weeks

  4. Vascular endothelial function measured by endo-PAT

    Time frame: 7 weeks

  5. Vascular endothelial function measured by endo-PAT

    Time frame: 13 weeks

  6. Vascular endothelial function measured by endo-PAT

    Time frame: 24 weeks

  7. Lipids and lipoproteins

    Time frame: 7 weeks

  8. Lipids and lipoproteins

    Time frame: 13 weeks

  9. Lipids and lipoproteins

    Time frame: 24 weeks

  10. Inflammatory markers

    Time frame: 7 weeks

  11. Inflammatory markers

    Time frame: 13 weeks

  12. Inflammatory markers

    Time frame: 24 weeks

  13. Dietary analysis

    Time frame: 52 weeks

    macro-and micronutrients

  14. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference) TG, HDL-C, glucose and BP

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Registry information

Official study title

BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors: Effects on Metabolic Syndrome (BOLD-X)

Acronym: BOLD-X

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 13, 2009
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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