Cardiovascular Disease, Cardiovascular Risk Factors, Dietary Modification
Conditions
Brief summary
A randomized controlled clinical trial comparing the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.
Detailed description
Background: Increased intake of saturated fat may influence LDL cholesterol and other cardiovascular risk factors different in normal weight and obese subjects. Methods: The study is a randomized controlled clinical trial in 84 men and women between 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (\>3.0 mmol/l). Dietary intervention: Randomization will be to one of two balanced weight maintenance Mediterranean-type diets that differ in their fat sources: an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods, and a control diet with whole fat dairy and meat with saturated fats that are not fat reduced. Primary research question: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol. Secondary research questions: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on cardiometabolic risk factors including insulin resistance, inflammation and serum PCSK9 in normal weight and obese individuals.
Interventions
OTHERunsaturated fat for saturated fat
Substituting unsaturated fat for saturated fat
OTHERsaturated fat
a control diet with whole fat dairy and meat with saturated fats that are not fat reduced
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women aged 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (\> 3.0 mmol/l).
Exclusion criteria
* Diabetes types 1 and 2 * History of CVD including myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, transient ischemic attack (TIA) or other atherosclerotic disease, eating disorder and other secondary causes of hyperlipidemia. * Use of statins or other cholesterol-modifying drugs. * Genetic lipid disorder. * Gastrointestinal disorders that limit food choices. * Psychiatric illness, drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum lipids in normal weight and obese subjects with elevated LDL cholesterol. | 10 weeks | Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein in normal weight and obese individuals | 10 weeks | Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on c-reactive protein in normal weight and obese individuals |
| Serum PCSK9 in normal weight and obese individuals | 10 weeks | Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on inflammation in normal weight and obese individuals |
| Fasting glucose and HbA1C | 10 weeks | Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on fasting glucose and HbA1C |
Countries
Norway
Outcome results
None listed