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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-02-28

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.

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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.

Conditions

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Cardiovascular Disease Dietary Modification Cardiovascular Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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unsaturated fat

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

Group Type EXPERIMENTAL

unsaturated fat for saturated fat

Intervention Type OTHER

Substituting unsaturated fat for saturated fat

saturated fat

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

Group Type ACTIVE_COMPARATOR

saturated fat

Intervention Type OTHER

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

Interventions

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unsaturated fat for saturated fat

Substituting unsaturated fat for saturated fat

Intervention Type OTHER

saturated fat

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

Intervention Type OTHER

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes