Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects

Study Overview
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Brief Summary
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In this study the investigators aimed at measuring the effect of a two-week high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.

Detailed Description
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HDL particles can change their composition and function in response to a variety of pathological conditions and environmental stimuli. It has been previously shown that a western diet is able to drastically modify biochemical composition, anti-inflammatory and anti-oxidant properties of HDL in animals. In humans little is known on the role of diet on HDL function and composition.

Official Title
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Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects

Conditions
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Lipids

Intervention / Treatment
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* Dietary Supplement: Low fat/cholesterol diet
* Dietary Supplement: High fat/cholesterol diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥ 18 and ≤40 years of age Lean or overweight (BMI: 18 to 29,9 kg/m2) Normal liver and kidney function Normal thyroid function Stable weight in the last 3 months Read and understood the informed consent form and signed it voluntarily Exclusion Criteria: Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases Chronic use of drugs or vitamin supplements Smoking Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High fat/cholesterol diet<br>High-fat/high-cholesterol (HFHC) normocaloric diet for 14 days. | Dietary Supplement: High fat/cholesterol diet<br>* The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day<br>|
| Experimental: Low fat/cholesterol diet<br>Low-fat/low-cholesterol (LFLC) normocaloric diet for 14 days. | Dietary Supplement: Low fat/cholesterol diet<br>* The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dichlorofluorescein fluorescence slope |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hydroxyeicosatetraenoic acid |  | 14 days | 
| hydroxyoctadecadienoic acid |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HDL biochemical composition and function