Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

Sponsor

Instituto Aragones de Ciencias de la Salud (Other)

Overall Status

Completed

CT.gov ID

NCT02259153

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lipid Metabolism Disorders Sterols Diet, High-Fat Cholesterol Fatty Acids Hyperlipidemias	Behavioral: Changes in cholesterol metabolism Other: Lean red meat diet Other: Fat red meat diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lean red meat diet 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 Other: Lean red meat diet
Active Comparator: Fat red meat diet 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 Other: Fat red meat diet

Arm

Intervention/Treatment

Active Comparator: Lean red meat diet

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

Other: Lean red meat diet

Active Comparator: Fat red meat diet

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

Other: Fat red meat diet

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Instituto Aragones de Ciencias de la Salud

Investigators

Principal Investigator: Fernando Civeira, MD, PhD, Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Principal Investigator: Lucía Baila-Rueda, MSc, Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)