Clinical trial NCT00852267: Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
Official title: Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Cardiovascular Disease
Atherogenic Dyslipidemia
Keywords: cholesterol
diet
protein
carbohydrate
saturated fat
LDL subclass
healthy volunteers
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: National Cattlemen's Beef Association
First posted: 2009-02-26
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Total Cholesterol
timeFrame: 3 weeks, 8 weeks, and 13 weeks
measure: Non-HDL Cholesterol
timeFrame: 3 weeks, 8 weeks, and 13 weeks
measure: Apolipoprotein B
timeFrame: 3 weeks, 8 weeks, and 13 weeks
measure: LDL-Cholesterol/HDL-Cholesterol
timeFrame: 3 weeks, 8 weeks, and 13 weeks
measure: Apolipoprotein B/Apolipoprotein AI
timeFrame: 3 weeks, 8 weeks, and 13 weeks
Secondary outcomes:
measure: LDL peak diameter
timeFrame: 3 weeks, 8 weeks, and 13 weeks
measure: LDL subclass 3 (LDL3)
timeFrame: 3 weeks, 8 weeks, and 13 weeks
measure: HDL subclass 2 (HDL2)
timeFrame: 3 weeks, 8 weeks, and 13 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Cholesterol Research Center
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Ronald M Krauss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.