Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lean red meat diet

Participants were given 350 g per day of lean red meat to incorporate to their usual diet for ten days.

Group Type ACTIVE_COMPARATOR

Changes in cholesterol metabolism

Intervention Type BEHAVIORAL

Lean red meat diet

Intervention Type OTHER

Fat red meat diet

Participants were given 350 g per day of fat red meat to incorporate to their usual diet for ten days.

Group Type ACTIVE_COMPARATOR

Changes in cholesterol metabolism

Intervention Type BEHAVIORAL

Fat red meat diet

Intervention Type OTHER

Interventions

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Changes in cholesterol metabolism

Intervention Type BEHAVIORAL

Lean red meat diet

Intervention Type OTHER

Fat red meat diet

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Fernando Civeira

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernando Civeira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)

Lucía Baila-Rueda, MSc

Role: PRINCIPAL_INVESTIGATOR

Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)