Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

Study Overview
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Brief Summary
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The objective of the study is to assess the effect of two diets with different fat composition on cholesterol metabolism. The study was a randomized cross-over trial where volunteers follow two study periods with different types of meat (lean and fat red meat) separately by a ten days wash-out period. At the beginning of the study and after the study periods the following parameters are determined: anthropometric (weight, waist, circumference and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid, glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol, campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout along the study in order to demonstrate the effect of different red meat on the hepatic metabolism of cholesterol.

Official Title
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A Randomized Study to Assess the Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

Conditions
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Lipid Metabolism Disorders, Sterols, Diet, High-Fat, Cholesterol, Fatty Acids, Hyperlipidemias

Intervention / Treatment
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* Behavioral: Changes in cholesterol metabolism
* Other: Lean red meat diet
* Other: Fat red meat diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normolipemic healthy subjects defined by levels of LDL cholesterol and triglycerides below the 90th percentile adjusted for age and sex. Diet and stable lifestyle with controllable feeding. Exclusion Criteria: Pregnancy or intention of pregnancy during the study. Lipid lowering drugs in the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lean red meat diet<br>Participants were given 350 g per day of lean red meat to incorporate to their usual diet for ten days. | Behavioral: Changes in cholesterol metabolism<br> <br> Other: Lean red meat diet<br> <br> |
| Active Comparator: Fat red meat diet<br>Participants were given 350 g per day of fat red meat to incorporate to their usual diet for ten days. | Behavioral: Changes in cholesterol metabolism<br> <br> Other: Fat red meat diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid profile |  | Baseline and after 10 days of intervention | 
| Changes in non cholesterol sterols and oxysterols serum concentrations |  | Baseline and after 10 days of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipids, Non Cholesterol Sterols, Oxysterols, Cholesterol Metabolism