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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
History of Changes

February 24, 2009
October 4, 2011
January 2008
August 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00852267 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Healthy
  • Cardiovascular Disease
  • Atherogenic Dyslipidemia
  • Other: High Carbohydrate, High Saturated Fat Diet
    50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)
  • Other: Low Carbohydrate, High Saturated Fat Diet
    31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)
  • Other: Low Carbohydrate, Low Saturated Fat Diet
    31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)
  • Active Comparator: High CHO, High SatFat Diet
    Intervention: Other: High Carbohydrate, High Saturated Fat Diet
  • Experimental: Low CHO, High SatFat Diet
    Intervention: Other: Low Carbohydrate, High Saturated Fat Diet
  • Experimental: Low CHO, Low SatFat Diet
    Intervention: Other: Low Carbohydrate, Low Saturated Fat Diet
Mangravite LM, Chiu S, Wojnoonski K, Rawlings RS, Bergeron N, Krauss RM. Changes in atherogenic dyslipidemia induced by carbohydrate restriction in men are dependent on dietary protein source. J Nutr. 2011 Dec;141(12):2180-5. Epub 2011 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2009
August 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852267
2007-068
No
Ronald Krauss, M.D., Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
National Cattlemen's Beef Association
Principal Investigator: Ronald M Krauss, M.D. Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP