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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Modified DASH Diet; Dietary supplement: BOLD Diet; Dietary supplement: BOLD-X Diet

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: DASH diet
Experimental: BOLD diet	Dietary supplement: BOLD Diet; Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day); Other Names: 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 Names: Low fat, moderate protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP	2 weeks
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP	7 weeks
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP	13 weeks
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular endothelial function measured by endo-PAT		2 weeks
Lipids and lipoproteins		2 weeks
Inflammatory markers		2 weeks
Vascular endothelial function measured by endo-PAT		7 weeks
Vascular endothelial function measured by endo-PAT		13 weeks
Vascular endothelial function measured by endo-PAT		24 weeks
Lipids and lipoproteins		7 weeks
Lipids and lipoproteins		13 weeks
Lipids and lipoproteins		24 weeks
Inflammatory markers		7 weeks
Inflammatory markers		13 weeks
Inflammatory markers		24 weeks
Dietary analysis	macro-and micronutrients	52 weeks
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference) TG, HDL-C, glucose and BP		52 weeks

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Cattlemen's Beef Association
• Investigators: Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Publications and helpful links

General Publications

• Hill AM, Harris Jackson KA, Roussell MA, West SG, Kris-Etherton PM. Type and amount of dietary protein in the treatment of metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2015 Oct;102(4):757-70. doi: 10.3945/ajcn.114.104026. Epub 2015 Sep 9.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimated): July 13, 2009

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Metabolic syndrome; CVD; Lean Beef
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: PKE BOLD-X