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Clinical Trials/NCT00852267
NCT00852267CompletedNot Applicable

Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

UCSF Benioff Children's Hospital Oakland1 site in 1 country67 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
67
Locations
1
Primary Endpoint
Total Cholesterol

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

High CHO, High SatFat Diet

Active Comparator

Intervention: High Carbohydrate, High Saturated Fat Diet (Other)

Low CHO, High SatFat Diet

Experimental

Intervention: Low Carbohydrate, High Saturated Fat Diet (Other)

Low CHO, Low SatFat Diet

Experimental

Intervention: Low Carbohydrate, Low Saturated Fat Diet (Other)

Outcomes

Primary Outcomes

Total Cholesterol

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

Non-HDL Cholesterol

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

Apolipoprotein B

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

LDL-Cholesterol/HDL-Cholesterol

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

Apolipoprotein B/Apolipoprotein AI

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

Secondary Outcomes

  • LDL subclass 3 (LDL3)(3 weeks, 8 weeks, and 13 weeks)
  • LDL peak diameter(3 weeks, 8 weeks, and 13 weeks)
  • HDL subclass 2 (HDL2)(3 weeks, 8 weeks, and 13 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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