Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

October 3, 2014 updated by: Fernando Civeira, Instituto Aragones de Ciencias de la Salud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in lipid profile
Time Frame: Baseline and after 10 days of intervention
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
Baseline and after 10 days of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Aragones de Ciencias de la Salud

Investigators

  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (ESTIMATE)

October 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 3, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEICA;PI13-00106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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