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Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

Primary Purpose

Healthy, Cardiovascular Disease, Atherogenic Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Carbohydrate, High Saturated Fat Diet
Low Carbohydrate, High Saturated Fat Diet
Low Carbohydrate, Low Saturated Fat Diet
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring cholesterol, diet, protein, carbohydrate, saturated fat, LDL subclass, healthy volunteers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cholesterol Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

High CHO, High SatFat Diet

Low CHO, High SatFat Diet

Low CHO, Low SatFat Diet

Arm Description

Outcomes

Primary Outcome Measures

Total Cholesterol
Non-HDL Cholesterol
Apolipoprotein B
LDL-Cholesterol/HDL-Cholesterol
Apolipoprotein B/Apolipoprotein AI

Secondary Outcome Measures

LDL peak diameter
LDL subclass 3 (LDL3)
HDL subclass 2 (HDL2)

Full Information

First Posted
February 24, 2009
Last Updated
December 22, 2020
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
National Cattlemen's Beef Association
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1. Study Identification

Unique Protocol Identification Number
NCT00852267
Brief Title
Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
Official Title
Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
National Cattlemen's Beef Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Cardiovascular Disease, Atherogenic Dyslipidemia
Keywords
cholesterol, diet, protein, carbohydrate, saturated fat, LDL subclass, healthy volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High CHO, High SatFat Diet
Arm Type
Active Comparator
Arm Title
Low CHO, High SatFat Diet
Arm Type
Experimental
Arm Title
Low CHO, Low SatFat Diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High Carbohydrate, High Saturated Fat Diet
Intervention Description
50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)
Intervention Type
Other
Intervention Name(s)
Low Carbohydrate, High Saturated Fat Diet
Intervention Description
31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)
Intervention Type
Other
Intervention Name(s)
Low Carbohydrate, Low Saturated Fat Diet
Intervention Description
31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)
Primary Outcome Measure Information:
Title
Total Cholesterol
Time Frame
3 weeks, 8 weeks, and 13 weeks
Title
Non-HDL Cholesterol
Time Frame
3 weeks, 8 weeks, and 13 weeks
Title
Apolipoprotein B
Time Frame
3 weeks, 8 weeks, and 13 weeks
Title
LDL-Cholesterol/HDL-Cholesterol
Time Frame
3 weeks, 8 weeks, and 13 weeks
Title
Apolipoprotein B/Apolipoprotein AI
Time Frame
3 weeks, 8 weeks, and 13 weeks
Secondary Outcome Measure Information:
Title
LDL peak diameter
Time Frame
3 weeks, 8 weeks, and 13 weeks
Title
LDL subclass 3 (LDL3)
Time Frame
3 weeks, 8 weeks, and 13 weeks
Title
HDL subclass 2 (HDL2)
Time Frame
3 weeks, 8 weeks, and 13 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Krauss, M.D.
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cholesterol Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22031660
Citation
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. doi: 10.3945/jn.111.139477. Epub 2011 Oct 26.
Results Reference
derived

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Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

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