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Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

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ClinicalTrials.gov Identifier: NCT02259153
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Changes in lipid profile [ Time Frame: Baseline and after 10 days of intervention ]
  2. Changes in non cholesterol sterols and oxysterols serum concentrations [ Time Frame: Baseline and after 10 days of intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259153


Sponsors and Collaborators
Instituto Aragones de Ciencias de la Salud
Investigators
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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)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando Civeira, Professor, Instituto Aragones de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT02259153    
Other Study ID Numbers: CEICA;PI13-00106
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014
Keywords provided by Fernando Civeira, Instituto Aragones de Ciencias de la Salud:
Lipids
Non Cholesterol Sterols
Oxysterols
Cholesterol Metabolism
Additional relevant MeSH terms:
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Hyperlipidemias
Metabolic Diseases
Lipid Metabolism Disorders
Dyslipidemias