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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00852267
Other study ID # 2007-068
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2008
Est. completion date December 2009

Study information

Verified date December 2020
Source UCSF Benioff Children's Hospital Oakland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date December 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
High Carbohydrate, High Saturated Fat Diet
50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)
Low Carbohydrate, High Saturated Fat Diet
31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)
Low Carbohydrate, Low Saturated Fat Diet
31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)

Locations

Country Name City State
United States Cholesterol Research Center Berkeley California

Sponsors (2)

Lead Sponsor Collaborator
UCSF Benioff Children's Hospital Oakland National Cattlemen's Beef Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Cholesterol 3 weeks, 8 weeks, and 13 weeks
Primary Non-HDL Cholesterol 3 weeks, 8 weeks, and 13 weeks
Primary Apolipoprotein B 3 weeks, 8 weeks, and 13 weeks
Primary LDL-Cholesterol/HDL-Cholesterol 3 weeks, 8 weeks, and 13 weeks
Primary Apolipoprotein B/Apolipoprotein AI 3 weeks, 8 weeks, and 13 weeks
Secondary LDL peak diameter 3 weeks, 8 weeks, and 13 weeks
Secondary LDL subclass 3 (LDL3) 3 weeks, 8 weeks, and 13 weeks
Secondary HDL subclass 2 (HDL2) 3 weeks, 8 weeks, and 13 weeks
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