Genetic and Metabolism of Post-prandial HDL Particles (HDL-PP)

August 26, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Influence of TaqIB (rs708272) Polymorphism in Cholesteryl Ester Transfer Protein (CETP) Gene on Functionality of HDL Particles, in the Pathway of Reverse Transport of Fasting and Post-prandial Cholesterol.

Reverse cholesterol transport (RCT) pathway explains the anti-atherosclerosis role of HDL. Post prandial hypertriglyceridemia is highly predictive of atherosclerosis. TaqIB polymorphism in CETP gene plays a role on HDL particles, and might give a link between TaqIB polymorphism and the cardioprotective efficiency of HDL particles. Our main objective was to compare post-prandial HDL particles between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG), and their ability to mediate cellular cholesterol efflux, via SR-BI Scavenger Receptor class B type I (SR-BI) , ABCG1 and ABCA1 pathways.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background:

This trial focuses on anti-atherogenic properties functions of HDL lipoproteins, particularly those linked to reverse transport cholesterol (RCT) pathway, genetic factors involved in plasmatic HDL-C and post-prandial metabolism. The post-prandial period is associated with an activation of the RCT with an increase in Cholesteryl ester transfer protein (CETP), in plasmatic HDL particles. There is also an increase of HDL particles ability to mediate cellular cholesterol efflux, via SR-BI and ABCG1 pathways. TaqIB polymorphism is associated with a variation of the plasma to mediate cellular cholesterol efflux.

Aim of the study:

The investigators were aiming to test the hypothesis that the genetic variability of HDL-C is associated with structural and functional variability of post-prandial HDL particles and particularly in their ability to mediate the initial step of RCT.

Intervention:

The study aimed to include n=50 patients with a TaqIB AA polymorphism and 50 patients with a GG TaqIB polymorphism. Blood samples were performed fasted, before and after intake of a standardized test meal at 5 different time : H0 before the meal, H2, H4, H6 and H8 after the meal.

Explorations:

For the fasted sample a full lipidic assessment was performed including the dosing of: triglyceridemia, HDL-C, apolipoprotein B (apoB), apolipoprotein AI. The plasmatic kinetic of triglyceridemia, apoB100, apo-48 and the activity of CETP was performed on each sample.

HDL particles were also explored with qualitative and quantitative assessment of the HDL fractions ability to mediate cholesterol efflux via each pathway : SR-BI, ABCA1 and ABCG1 in our cellular models.

The study therefore aimed to improve our knowledge of molecular mechanisms involved in HDL particles dysfunction in metabolic diseases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Centre d'Investigation Clinique Paris Est

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Affiliation to a national social security scheme
  2. Age between 18 and 60 years old
  3. Male subjects
  4. Participants harboring either a B2 (genotype AA) allele or a B1 (genotype GG) in TaqIB polymorphism of CETP gene
  5. Fasted plasmatic triglyceridemia < 300 mg/dL
  6. Free prior and informed written consent given by the participant

Exclusion Criteria:

  1. Participants with an history of symptomatic cardio-vascular disease (infarct, angina pectoris, acute coronary syndrome, cardiac surgery, endoluminal coronal intervention, stroke, symptomatic peripheral artery disease) within 6 months prior to inclusion.
  2. Triglyceridemia > 3 g/L
  3. Participants having other lipid-lowering agents than statin (fibrate, niacin, ezetimibe)
  4. Participants having a treatment (either systemic or local) which might interfere with the evaluation of study parameters.
  5. Excessive alcohol consumption, or any drug addiction. An excessive alcohol consumption is superior to 21 time 30 mL of alcohol or 120 mL of wine or 355 mL of beer.
  6. Regular smoker or smoking cessation within the last year
  7. Significant abnormality on the full blood count or plasmatic and urinary biochemistry analysis.

  8. Chronic or acute disease either life threatening or able to modify study results, including among others :

    1. Diabetes
    2. Renal diseases : nephrotic syndrome, chronic kidney failure and/or creatininemia > 1.7 time the upper limit of normal (ULN).
    3. Hypothyroidism defined by thyroid-stimulating hormone > 2x ULN
    4. Hepatobiliary disease or viral hepatitis B or C confirmed by transaminases > 2x ULN or alkaline phosphatase > 1.5x ULN or total bilirubinemia > 1.5x ULN at screening.
    5. Known HIV
    6. Gastro-intestinal disorder or disease that might modify intestinal absorption, bariatric surgery.
  9. Participant who might interfere with the quality of the study or might compromise the study according to the investigator.
  10. Participant currently enrolled in another study or in the exclusion period of another study.
  11. Participants with uncontrolled hypertension defined by a systolic blood pressure > 140 mmHg or a diastolic blood pressure > 90 mmHg.
  12. Participants with a C reactive protein (CRP) > 5mg/L
  13. Participants with a E2/E2 phenotype of apolipoprotein E.
  14. Blood donation or product derived-from blood donation within the last 3 months prior to the test meal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standardized meal

Standardized meal for :

50 patients with a TaqIB AA polymorphism 50 patients with a TaqIB GG polymorphism
Other: Standardized meal
Blood samples performed at 5 different times : H0 before the meal, H2, H4, H6 and H8 after the meal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of post-prandial HDL particles
Time Frame: before the meal (time = 0 hour) vs 2 hours after
Compare post-prandial HDL particles area under curve (AUC) between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG)
before the meal (time = 0 hour) vs 2 hours after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of post-prandial HDL particles
Time Frame: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Compare post-prandial HDL particles area under curve (AUC) between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG), and their ability to mediate cellular cholesterol efflux, via SR-BI, ABCG1 and ABCA1 pathways.
before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Efflux capacity of postprandial HDL particles
Time Frame: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
- Compare the increase of efflux capacity of postprandial HDL particles between individuals harboring a B2 allele compared to those harboring a B1 allele.
before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Area under curves of triglyceridemia of apoB100 and apoB48
Time Frame: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Compare area under curves of triglyceridemia of apoB100 and apoB48 between individuals harboring a B2 allele (genotype AA) in the TaqIB polymorphism of the CETP gene.
before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Plasmatic concentrations of apoB100
Time Frame: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Compare plasmatic concentrations of apoB100 between individuals harboring a B2 allele (genotype AA) in the TaqIB polymorphism of the CETP gene.
before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Correlation between the area under curve of triglyceridemia and the efflux capacity of HDL particles.
Time Frame: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Investigate the correlation between the area under curve of triglyceridemia and the efflux capacity of HDL particles.
before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karim Ammour, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C10-57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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