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Clinical Trials/NCT02259153
NCT02259153
Completed
Not Applicable

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

Instituto Aragones de Ciencias de la Salud0 sites20 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lipid Metabolism Disorders
Sponsor
Instituto Aragones de Ciencias de la Salud
Enrollment
20
Primary Endpoint
Changes in lipid profile
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
August 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fernando Civeira

Professor

Instituto Aragones de Ciencias de la Salud

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in lipid profile

Time Frame: Baseline and after 10 days of intervention

Changes in non cholesterol sterols and oxysterols serum concentrations

Time Frame: Baseline and after 10 days of intervention

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