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

University of Oslo (UIO)

Status: Completed

Conditions: Dietary Modification; Cardiovascular Risk Factors; Cardiovascular Disease

Treatments: Other: unsaturated fat for saturated fat; Other: saturated fat

Study type: Interventional

Funder types: Other

Identifiers

NCT02589769

1786 (REK(

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

unsaturated fat

Experimental group

Description:

an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods

Treatment:

Other: unsaturated fat for saturated fat

saturated fat

Active Comparator group

Description:

a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.

Treatment:

Other: saturated fat