Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259153
• Other study ID #: CEICA;PI13-00106
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: October 3, 2014
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Instituto Aragones de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholesterol
• Diet, High-Fat
• Fatty Acids
• Hyperlipidemias
• Lipid Metabolism Disorders
• Metabolic Diseases
• Sterols

Intervention

Behavioral:
• Changes in cholesterol metabolism

Other:
• Lean red meat diet

• Fat red meat diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Aragones de Ciencias de la Salud

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lipid profile		Baseline and after 10 days of intervention	No
Primary	Changes in non cholesterol sterols and oxysterols serum concentrations		Baseline and after 10 days of intervention	No