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

This study has been completed.
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT00937638
First received: June 18, 2009
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Metabolic Syndrome
Cardiovascular Disease
Dietary Supplement: BOLD Diet
Dietary Supplement: BOLD-X Diet
Dietary Supplement: Modified DASH Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors: Effects on Metabolic Syndrome (BOLD-X)

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vascular endothelial function measured by endo-PAT [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Lipids and lipoproteins [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Vascular endothelial function measured by endo-PAT [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Vascular endothelial function measured by endo-PAT [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Vascular endothelial function measured by endo-PAT [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Lipids and lipoproteins [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Lipids and lipoproteins [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Lipids and lipoproteins [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Dietary analysis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    macro-and micronutrients

  • Criteria for Metabolic Syndrome: central obesity (weight, waist circumference) TG, HDL-C, glucose and BP [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified-DASH Diet Dietary Supplement: Modified DASH Diet
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 Name: DASH diet
Experimental: BOLD diet Dietary Supplement: BOLD Diet
Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day)
Other Name: Low fat, Step II diet
Experimental: BOLD-X Dietary Supplement: BOLD-X Diet
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 Name: Low fat, moderate protein

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937638

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
National Cattlemen's Beef Association
Investigators
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
  More Information

No publications provided

Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT00937638     History of Changes
Other Study ID Numbers: PKE BOLD-X
Study First Received: June 18, 2009
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Metabolic syndrome
Lean Beef
CVD

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014