Atherogenic Dyslipidemia, Cardiovascular Disease, Healthy
Conditions
Keywords
cholesterol, diet, protein, carbohydrate, saturated fat, LDL subclass, healthy volunteers
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.
Interventions
OTHERHigh Carbohydrate, High Saturated Fat Diet
50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)
OTHERLow Carbohydrate, High Saturated Fat Diet
31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)
OTHERLow Carbohydrate, Low Saturated Fat Diet
31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)
Sponsors
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
UCSF Benioff Children's Hospital Oakland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apolipoprotein B/Apolipoprotein AI | 3 weeks, 8 weeks, and 13 weeks |
| Non-HDL Cholesterol | 3 weeks, 8 weeks, and 13 weeks |
| Apolipoprotein B | 3 weeks, 8 weeks, and 13 weeks |
| LDL-Cholesterol/HDL-Cholesterol | 3 weeks, 8 weeks, and 13 weeks |
| Total Cholesterol | 3 weeks, 8 weeks, and 13 weeks |
Secondary
| Measure | Time frame |
|---|---|
| LDL subclass 3 (LDL3) | 3 weeks, 8 weeks, and 13 weeks |
| HDL subclass 2 (HDL2) | 3 weeks, 8 weeks, and 13 weeks |
| LDL peak diameter | 3 weeks, 8 weeks, and 13 weeks |
Countries
United States
Outcome results
None listed