Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

Healthy Clinical Trial

Official title:

Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852267
• Other study ID #: 2007-068
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atherogenic Dyslipidemia
• Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemias
• Healthy

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