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Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

NCT ID: NCT00852267

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Healthy Cardiovascular Disease Atherogenic Dyslipidemia

Keywords

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cholesterol diet protein carbohydrate saturated fat LDL subclass healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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High CHO, High SatFat Diet

Group Type ACTIVE_COMPARATOR

High Carbohydrate, High Saturated Fat Diet

Intervention Type OTHER

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

Low CHO, High SatFat Diet

Group Type EXPERIMENTAL

Low Carbohydrate, High Saturated Fat Diet

Intervention Type OTHER

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

Low CHO, Low SatFat Diet

Group Type EXPERIMENTAL

Low Carbohydrate, Low Saturated Fat Diet

Intervention Type OTHER

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

Interventions

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High Carbohydrate, High Saturated Fat Diet

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

Intervention Type OTHER

Low Carbohydrate, High Saturated Fat Diet

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

Intervention Type OTHER

Low Carbohydrate, Low Saturated Fat Diet

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cattlemen's Beef Association

INDUSTRY

Sponsor Role collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald M Krauss, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

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Cholesterol Research Center

Berkeley, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22031660 (View on PubMed)

Other Identifiers

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2007-068

Identifier Type: -

Identifier Source: org_study_id