NCT Number: NCT02259153
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.
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Lean red meat diet
OtherFat red meat diet
OtherPrimary outcomes
-
Changes in lipid profile
Time frame: 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
Sponsors and collaborators
Lead sponsor
Instituto Aragones de Ciencias de la Salud
Other Gov
Registry information
Official study title
A Randomized Study to Assess the Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Oct 8, 2014
- Registry last updated
- Oct 8, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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