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

Primary Purpose

Metabolic Syndrome, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BOLD Diet
BOLD-X Diet
Modified DASH Diet
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Lean Beef, CVD

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Modified-DASH Diet

BOLD diet

BOLD-X

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Vascular endothelial function measured by endo-PAT
Lipids and lipoproteins
Inflammatory markers
Vascular endothelial function measured by endo-PAT
Vascular endothelial function measured by endo-PAT
Vascular endothelial function measured by endo-PAT
Lipids and lipoproteins
Lipids and lipoproteins
Lipids and lipoproteins
Inflammatory markers
Inflammatory markers
Inflammatory markers
Dietary analysis
macro-and micronutrients
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference) TG, HDL-C, glucose and BP

Full Information

First Posted
June 18, 2009
Last Updated
August 16, 2023
Sponsor
Penn State University
Collaborators
National Cattlemen's Beef Association
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1. Study Identification

Unique Protocol Identification Number
NCT00937638
Brief Title
Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
National Cattlemen's Beef Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Cardiovascular Disease
Keywords
Metabolic syndrome, Lean Beef, CVD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified-DASH Diet
Arm Type
Experimental
Arm Title
BOLD diet
Arm Type
Experimental
Arm Title
BOLD-X
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
BOLD Diet
Other Intervention Name(s)
Low fat, Step II diet
Intervention Description
Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
BOLD-X Diet
Other Intervention Name(s)
Low fat, moderate protein
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified DASH Diet
Other Intervention Name(s)
DASH diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP
Time Frame
2 weeks
Title
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP
Time Frame
7 weeks
Title
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP
Time Frame
13 weeks
Title
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Vascular endothelial function measured by endo-PAT
Time Frame
2 weeks
Title
Lipids and lipoproteins
Time Frame
2 weeks
Title
Inflammatory markers
Time Frame
2 weeks
Title
Vascular endothelial function measured by endo-PAT
Time Frame
7 weeks
Title
Vascular endothelial function measured by endo-PAT
Time Frame
13 weeks
Title
Vascular endothelial function measured by endo-PAT
Time Frame
24 weeks
Title
Lipids and lipoproteins
Time Frame
7 weeks
Title
Lipids and lipoproteins
Time Frame
13 weeks
Title
Lipids and lipoproteins
Time Frame
24 weeks
Title
Inflammatory markers
Time Frame
7 weeks
Title
Inflammatory markers
Time Frame
13 weeks
Title
Inflammatory markers
Time Frame
24 weeks
Title
Dietary analysis
Description
macro-and micronutrients
Time Frame
52 weeks
Title
Criteria for Metabolic Syndrome: central obesity (weight, waist circumference) TG, HDL-C, glucose and BP
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny M Kris-Etherton, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26354540
Citation
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.
Results Reference
derived

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

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