NCT02259153

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

October 1, 2014

Last Update Submit

October 3, 2014

Conditions

Lipid Metabolism DisordersSterolsDiet, High-FatCholesterolFatty AcidsHyperlipidemias

Keywords

LipidsNon Cholesterol SterolsOxysterolsCholesterol Metabolism

Outcome Measures

Primary Outcomes (2)

  • Changes in lipid profile

    Baseline and after 10 days of intervention

  • Changes in non cholesterol sterols and oxysterols serum concentrations

    Baseline and after 10 days of intervention

Study Arms (2)

Lean red meat diet

ACTIVE COMPARATOR

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

Behavioral: Changes in cholesterol metabolismOther: Lean red meat diet

Fat red meat diet

ACTIVE COMPARATOR

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

Behavioral: Changes in cholesterol metabolismOther: Fat red meat diet

Interventions

Changes in cholesterol metabolismBEHAVIORAL
Fat red meat dietLean red meat diet
Lean red meat dietOTHER
Lean red meat diet
Fat red meat dietOTHER
Fat red meat diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy or intention of pregnancy during the study.
  • Lipid lowering drugs in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26232911DERIVED

MeSH Terms

Conditions

Lipid Metabolism DisordersHyperlipidemias

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesDyslipidemias

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 8, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

October 8, 2014

Record last verified: 2014-10