Back to resultsEffect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Primary Purpose
Lipid Metabolism Disorders, Sterols, Diet, High-Fat
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Changes in cholesterol metabolism
Lean red meat diet
Fat red meat diet
Sponsored by
About this trial
This is an interventional treatment trial for Lipid Metabolism Disorders focused on measuring Lipids, Non Cholesterol Sterols, Oxysterols, Cholesterol Metabolism
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lean red meat diet
Fat red meat diet
Arm Description
Participants were given 350 g per day of lean red meat to incorporate to their usual diet for ten days.
Participants were given 350 g per day of fat red meat to incorporate to their usual diet for ten days.
Outcomes
Primary Outcome Measures
Changes in lipid profile
Changes in non cholesterol sterols and oxysterols serum concentrations
Secondary Outcome Measures
Full Information
NCT ID
NCT02259153
First Posted
October 1, 2014
Last Updated
October 3, 2014
Sponsor
Instituto Aragones de Ciencias de la Salud
1. Study Identification
Unique Protocol Identification Number
NCT02259153
Brief Title
Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Official Title
A Randomized Study to Assess the Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Aragones de Ciencias de la Salud
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorders, Sterols, Diet, High-Fat, Cholesterol, Fatty Acids, Hyperlipidemias
Keywords
Lipids, Non Cholesterol Sterols, Oxysterols, Cholesterol Metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lean red meat diet
Arm Type
Active Comparator
Arm Description
Participants were given 350 g per day of lean red meat to incorporate to their usual diet for ten days.
Arm Title
Fat red meat diet
Arm Type
Active Comparator
Arm Description
Participants were given 350 g per day of fat red meat to incorporate to their usual diet for ten days.
Intervention Type
Behavioral
Intervention Name(s)
Changes in cholesterol metabolism
Intervention Type
Other
Intervention Name(s)
Lean red meat diet
Intervention Type
Other
Intervention Name(s)
Fat red meat diet
Primary Outcome Measure Information:
Title
Changes in lipid profile
Time Frame
Baseline and after 10 days of intervention
Title
Changes in non cholesterol sterols and oxysterols serum concentrations
Time Frame
Baseline and after 10 days of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Civeira, MD, PhD
Organizational Affiliation
Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucía Baila-Rueda, MSc
Organizational Affiliation
Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26232911
Citation
Baila-Rueda L, Mateo-Gallego R, Perez-Calahorra S, Lamiquiz-Moneo I, de Castro-Oros I, Cenarro A, Civeira F. Effect of different fat-enriched meats on non-cholesterol sterols and oxysterols as markers of cholesterol metabolism: Results of a randomized and cross-over clinical trial. Nutr Metab Cardiovasc Dis. 2015 Sep;25(9):853-859. doi: 10.1016/j.numecd.2015.06.008. Epub 2015 Jun 23.
Results Reference
derived
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Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
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