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

Metabolic Syndrome Clinical Trial

— BOLD-X  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937638
• Other study ID #: PKE BOLD-X
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: March 2012

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• BOLD Diet
Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day)
• 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
• 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

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Cattlemen's Beef Association

Country where clinical trial is conducted

United States, 

Outcome

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