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Completed

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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Key information

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

Changes in cholesterol metabolism

Behavioral

Lean red meat diet

Other

Fat red meat diet

Other

Primary outcomes

  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

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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