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Completed

NCT Number: NCT00852267

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cholesterol Research Center

Berkeley, California, 94705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Carbohydrate, High Saturated Fat Diet

Other

50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)

Low Carbohydrate, High Saturated Fat Diet

Other

31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)

Low Carbohydrate, Low Saturated Fat Diet

Other

31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)

Primary outcomes

  1. Total Cholesterol

    Time frame: 3 weeks, 8 weeks, and 13 weeks

  2. Non-HDL Cholesterol

    Time frame: 3 weeks, 8 weeks, and 13 weeks

  3. Apolipoprotein B

    Time frame: 3 weeks, 8 weeks, and 13 weeks

  4. LDL-Cholesterol/HDL-Cholesterol

    Time frame: 3 weeks, 8 weeks, and 13 weeks

  5. Apolipoprotein B/Apolipoprotein AI

    Time frame: 3 weeks, 8 weeks, and 13 weeks

Secondary outcomes

  1. LDL peak diameter

    Time frame: 3 weeks, 8 weeks, and 13 weeks

  2. LDL subclass 3 (LDL3)

    Time frame: 3 weeks, 8 weeks, and 13 weeks

  3. HDL subclass 2 (HDL2)

    Time frame: 3 weeks, 8 weeks, and 13 weeks

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 26, 2009
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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