Lipid Metabolism DisordersNCT02259153
Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
A study testing Changes in cholesterol metabolism, Lean red meat diet and Fat red meat diet in people with Lipid Metabolism Disorders and Sterols, run by Instituto Aragones de Ciencias de la Salud.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders, Sterols, Diet, High-Fat
- What is being tested?
- Changes in cholesterol metabolism, Lean red meat diet and Fat red meat diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or intention of pregnancy during the study.
- Lipid lowering drugs in the last 3 months.
About this study
Official title: A Randomized Study to Assess the 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.
- Conditions
- Lipid Metabolism Disorders, Sterols, Diet, High-Fat, Cholesterol, Fatty Acids, Hyperlipidemias
- Being tested
- Changes in cholesterol metabolism, Lean red meat diet, Fat red meat diet
- Keywords
- Lipids, Non Cholesterol Sterols, Oxysterols, Cholesterol Metabolism
- Medical subject headings
- Lipid Metabolism Disorders, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in cholesterol metabolismBehavioural
Lean red meat dietOther
Fat red meat dietOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Changes in cholesterol metabolism; Other: 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. Receives: Behavioral: Changes in cholesterol metabolism; Other: Fat red meat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipid profile
Measured: Baseline and after 10 days of intervention
Changes in non cholesterol sterols and oxysterols serum concentrations
Measured: Baseline and after 10 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Aragones de Ciencias de la Salud
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Civeira, Instituto Aragones de Ciencias de la Salud
- Investigators
- Fernando Civeira, MD, PhD, Principal investigator, Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)Lucía Baila-Rueda, MSc, Principal investigator, Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259153
- Sponsor's protocol ID
- CEICA;PI13-00106
- Status last verified
- Oct 2014
- First submitted
- 1 Oct 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
Publications
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.
PubMed 26232911
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Assess the Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
- ClinicalTrials.gov ID
- NCT02259153
- Acronym / sponsor ID
- CEICA;PI13-00106
- Conditions
- Lipid Metabolism Disorders, Sterols, Diet, High-Fat, Cholesterol, Fatty Acids, Hyperlipidemias
- Keywords
- Lipids, Non Cholesterol Sterols, Oxysterols, Cholesterol Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Aragones de Ciencias de la SaludOther government
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean red meat diet | Active comparator | Behavioral: Changes in cholesterol metabolism, Other: Lean red meat dietParticipants were given 350 g per day of lean red meat to incorporate to their usual diet for ten days. |
| Fat red meat diet | Active comparator | Behavioral: Changes in cholesterol metabolism, Other: Fat red meat dietParticipants were given 350 g per day of fat red meat to incorporate to their usual diet for ten days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnancy or intention of pregnancy during the study.
- Lipid lowering drugs in the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changes in cholesterol metabolism | Behavioural | Fat red meat diet, Lean red meat diet |
| Lean red meat diet | Other | Lean red meat diet |
| Fat red meat diet | Other | Fat red meat diet |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
- Derived from this study: PubMed 26232911Baila-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Civeira, MD, PhD principal investigator
Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Lucía Baila-Rueda, MSc principal investigator
Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Questions about this trial
What is this clinical trial studying?
A study testing Changes in cholesterol metabolism, Lean red meat diet and Fat red meat diet in people with Lipid Metabolism Disorders and Sterols, run by Instituto Aragones de Ciencias de la Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lipid profile (time frame: Baseline and after 10 days of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02259153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.