Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons

Conditions
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Cardiovascular Disease, Dietary Modification, Cardiovascular Risk Factors

Intervention / Treatment
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* Other: unsaturated fat for saturated fat
* Other: saturated fat


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unsaturated fat<br>an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods | Other: unsaturated fat for saturated fat<br>* Substituting unsaturated fat for saturated fat<br>|
| Active Comparator: saturated fat<br>a control diet with whole fat dairy and meat with saturated fats that are not fat reduced. | Other: saturated fat<br>* a control diet with whole fat dairy and meat with saturated fats that are not fat reduced<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lipids in normal weight and obese subjects with elevated LDL cholesterol. | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein in normal weight and obese individuals | 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 | 10 weeks | 
| Serum PCSK9 in normal weight and obese individuals | Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on inflammation in normal weight and obese individuals | 10 weeks | 
| Fasting glucose and HbA1C | Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on fasting glucose and HbA1C | 10 weeks |