Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

December 22, 2020 updated by: UCSF Benioff Children's Hospital Oakland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94705
        • Cholesterol Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Cholesterol
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks
Non-HDL Cholesterol
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks
Apolipoprotein B
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks
LDL-Cholesterol/HDL-Cholesterol
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks
Apolipoprotein B/Apolipoprotein AI
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
LDL peak diameter
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks
LDL subclass 3 (LDL3)
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks
HDL subclass 2 (HDL2)
Time Frame: 3 weeks, 8 weeks, and 13 weeks
3 weeks, 8 weeks, and 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCSF Benioff Children's Hospital Oakland

Collaborators

National Cattlemen's Beef Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (ESTIMATE)

February 26, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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