Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

Not Applicable

Completed

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

• Registration Number: NCT02259153
• Lead Sponsor: Instituto Aragones de Ciencias de la Salud

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2014-10
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-03
• Last Update Submitted: 2014-10-03
• Study First Posted: 2014-10-08
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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