Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

This study has been completed.
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00852267
First received: February 24, 2009
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to test whether replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will improve risk factors for cardiovascular disease.


Condition Intervention
Healthy
Cardiovascular Disease
Atherogenic Dyslipidemia
Other: High Carbohydrate, High Saturated Fat Diet
Other: Low Carbohydrate, High Saturated Fat Diet
Other: Low Carbohydrate, Low Saturated Fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Total Cholesterol [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]
  • Non-HDL Cholesterol [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]
  • LDL-Cholesterol/HDL-Cholesterol [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B/Apolipoprotein AI [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LDL peak diameter [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]
  • LDL subclass 3 (LDL3) [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]
  • HDL subclass 2 (HDL2) [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High CHO, High SatFat Diet Other: High Carbohydrate, High Saturated Fat Diet
50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)
Experimental: Low CHO, High SatFat Diet Other: Low Carbohydrate, High Saturated Fat Diet
31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)
Experimental: Low CHO, Low SatFat Diet Other: Low Carbohydrate, Low Saturated Fat Diet
31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)

Detailed Description:

The primary aim of this study is to test the hypothesis that replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will have beneficial effects on components of atherogenic dyslipidemia and postprandial lipoprotein response and that these effects will be independent of saturated fat intake.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Blood pressure less than 150/90
  • Body mass index (BMI)≥ 20 and ≤ 35 kg/m2
  • Non-smoker
  • Agrees not to consume alcohol during the study
  • Agrees to abstain from taking dietary supplements during the study
  • LDL-cholesterol and total cholesterol < 95th percentile for age and sex
  • Fasting triglycerides < 500 mg/dL
  • Fasting glucose concentration < 126 mg/dL
  • Hematocrit (HCT) ≥ 36%
  • At least three months of a weight-stable state (± 3% of body weight)

Exclusion Criteria:

  • Personal history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, diabetes, lung disease, bleeding disorder, liver or renal disease, HIV or of cancer (other than skin cancer) in the last five years
  • Taking drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent warfarin
  • Abnormal thyroid stimulating hormone (TSH)
  • Strength trains with resistance weights more than four hours per week
  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: NCT00852267

Locations
United States, California
Cholesterol Research Center
Berkeley, California, United States, 94705
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
National Cattlemen's Beef Association
Investigators
Principal Investigator: Ronald M Krauss, M.D. Children's Hospital & Research Center Oakland
  More Information

No publications provided by Children's Hospital & Research Center Oakland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald Krauss, M.D., Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT00852267     History of Changes
Other Study ID Numbers: 2007-068
Study First Received: February 24, 2009
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
cholesterol
diet
protein
carbohydrate
saturated fat
LDL subclass
healthy volunteers

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014