Clinical trial NCT02259153: Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Official title: A Randomized Study to Assess the Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism Disorders
Sterols
Diet, High-Fat
Cholesterol
Fatty Acids
Hyperlipidemias
Keywords: Lipids
Non Cholesterol Sterols
Oxysterols
Cholesterol Metabolism
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
First posted: 2014-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in lipid profile
timeFrame: Baseline and after 10 days of intervention
measure: Changes in non cholesterol sterols and oxysterols serum concentrations
timeFrame: Baseline and after 10 days of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
name: Fernando Civeira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
name: Lucía Baila-Rueda, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baila-Rueda L, Mateo-Gallego R, Perez-Calahorra S, Lamiquiz-Moneo I, de Castro-Oros I, Cenarro A, Civeira F. Effect of different fat-enriched meats on non-cholesterol sterols and oxysterols as markers of cholesterol metabolism: Results of a randomized and cross-over clinical trial. Nutr Metab Cardiovasc Dis. 2015 Sep;25(9):853-859. doi: 10.1016/j.numecd.2015.06.008. Epub 2015 Jun 23.