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

NCT00937638 | Completed

• 1 other identifier: PKE BOLD-X
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Metabolic Syndrome; Cardiovascular Disease

Keywords

Metabolic syndrome; Lean Beef; CVD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• 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

Study Arms (3)

Modified-DASH Diet

EXPERIMENTAL

Dietary Supplement: Modified DASH Diet

BOLD diet

EXPERIMENTAL

Dietary Supplement: BOLD Diet

BOLD-X

EXPERIMENTAL

Dietary Supplement: BOLD-X Diet

Interventions

BOLD Diet DIETARY_SUPPLEMENT

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

Also known as: Low fat, Step II diet

BOLD 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

Also known as: Low fat, moderate protein

BOLD-X

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

Also known as: DASH diet

Modified-DASH Diet

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• 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.

  PMID: 26354540 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases

Interventions

Diet, Fat-Restricted; Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Penny M Kris-Etherton, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: July 13, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)