Healthy VolunteersHDL-PPNCT03109067
Genetic and Metabolism of Post-prandial HDL Particles
A study testing Standardized meal in people with Healthy Volunteers, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Standardized meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2011to 21 Nov 2015
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Affiliation to a national social security scheme
- Age between 18 and 60 years old
- Male subjects
- Participants harboring either a B2 (genotype AA) allele or a B1 (genotype GG) in TaqIB polymorphism of CETP gene
- Fasted plasmatic triglyceridemia < 300 mg/dL
- Free prior and informed written consent given by the participant
Who cannot join
- 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.
- Triglyceridemia > 3 g/L
- Participants having other lipid-lowering agents than statin (fibrate, niacin, ezetimibe)
- Participants having a treatment (either systemic or local) which might interfere with the evaluation of study parameters.
- 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.
- Regular smoker or smoking cessation within the last year
Show all 20Show fewer
- Significant abnormality on the full blood count or plasmatic and urinary biochemistry analysis.
- Chronic or acute disease either life threatening or able to modify study results, including among others :
- Diabetes
- Renal diseases : nephrotic syndrome, chronic kidney failure and/or creatininemia > 1.7 time the upper limit of normal (ULN).
- Hypothyroidism defined by thyroid-stimulating hormone > 2x ULN
- 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.
- Known HIV
- Gastro-intestinal disorder or disease that might modify intestinal absorption, bariatric surgery.
- Participant who might interfere with the quality of the study or might compromise the study according to the investigator.
- Participant currently enrolled in another study or in the exclusion period of another study.
- Participants with uncontrolled hypertension defined by a systolic blood pressure > 140 mmHg or a diastolic blood pressure > 90 mmHg.
- Participants with a C reactive protein (CRP) > 5mg/L
- Participants with a E2/E2 phenotype of apolipoprotein E.
- Blood donation or product derived-from blood donation within the last 3 months prior to the test meal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Standardized meal
- Keywords
- Cholesterol, HDL, Postprandial Period, Polymorphism, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized mealOther
Blood samples performed at 5 different times : H0 before the meal, H2, H4, H6 and H8 after the meal
| Study group | Role | What they receive |
|---|---|---|
| Standardized meal | Experimental | Standardized meal for :
50 patients with a TaqIB AA polymorphism 50 patients with a TaqIB GG polymorphism Receives: Other: Standardized meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of post-prandial HDL particles
Compare post-prandial HDL particles area under curve (AUC) between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG)
Measured: before the meal (time = 0 hour) vs 2 hours after
Secondary outcomes (5)
Comparison of post-prandial HDL particles
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.
Measured: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Efflux capacity of postprandial HDL particles
- Compare the increase of efflux capacity of postprandial HDL particles between individuals harboring a B2 allele compared to those harboring a B1 allele.
Measured: 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
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.
Measured: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Plasmatic concentrations of apoB100
Compare plasmatic concentrations of apoB100 between individuals harboring a B2 allele (genotype AA) in the TaqIB polymorphism of the CETP gene.
Measured: 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.
Investigate the correlation between the area under curve of triglyceridemia and the efflux capacity of HDL particles.
Measured: before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start21 Sep 2011
- Primary completion21 Nov 2015
- Study completion21 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Same intervention for everyone, two different groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karim Ammour, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109067
- Sponsor's protocol ID
- C10-57
- Acronym
- HDL-PP
- Status last verified
- Jan 2017
- First submitted
- 1 Mar 2017
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lamaziere A, Rainteau D, Kc P, Humbert L, Gauliard E, Ichou F, Ponnaiah M, Bouby N, Salem JE, Mallet JM, Guerin M, Lesnik P. Distinct Postprandial Bile Acids Responses to a High-Calorie Diet in Men Volunteers Underscore Metabolically Healthy and Unhealthy Phenotypes. Nutrients. 2020 Nov 19;12(11):3545. doi: 10.3390/nu12113545.
PubMed 33228154Motte AM, Gall JG, Salem JE, Dasque E, Lebot M, Frisdal E, Galier S, Villard EF, Bouaziz-Amar E, Lacorte JM, Charbit B, Le Goff W, Lesnik P, Guerin M. Reduced Reverse Cholesterol Transport Efficacy in Healthy Men with Undesirable Postprandial Triglyceride Response. Biomolecules. 2020 May 25;10(5):810. doi: 10.3390/biom10050810.
PubMed 32466286Galier S, Darabi M, Ma F, Materne C, Guillas I, Le Goff W, Kontush A, Guerin M. Reduced Capacity of High-Density Lipoprotein to Acquire Free Cholesterol From Triglyceride-Rich Lipoproteins Is Associated With Elevated Postprandial Hypertriglyceridemia in Healthy Men. J Am Heart Assoc. 2024 Aug 6;13(15):e034770. doi: 10.1161/JAHA.123.034770. Epub 2024 Jul 31.
PubMed 39082393
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03109067
- Acronym / sponsor ID
- HDL-PP / C10-57
- Conditions
- Healthy Volunteers
- Keywords
- Cholesterol, HDL, Postprandial Period, Polymorphism, Genetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 21 Sep 2011 (actual)
- Primary completion
- 21 Nov 2015 (actual)
- Study completion
- 21 Nov 2015 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Same intervention for everyone, two different groups
| Arm | Type | Receives |
|---|---|---|
| Standardized meal | Experimental | Other: Standardized mealStandardized meal for : 50 patients with a TaqIB AA polymorphism 50 patients with a TaqIB GG polymorphism |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Affiliation to a national social security scheme
- Age between 18 and 60 years old
- Male subjects
- Participants harboring either a B2 (genotype AA) allele or a B1 (genotype GG) in TaqIB polymorphism of CETP gene
- Fasted plasmatic triglyceridemia < 300 mg/dL
Key exclusion criteria (20 listed)
- 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.
- Triglyceridemia > 3 g/L
- Participants having other lipid-lowering agents than statin (fibrate, niacin, ezetimibe)
- Participants having a treatment (either systemic or local) which might interfere with the evaluation of study parameters.
- 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.
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 |
|---|---|---|
| Standardized mealBlood samples performed at 5 different times : H0 before the meal, H2, H4, H6 and H8 after the meal | Other | Standardized meal |
Primary outcome
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)
5 secondary outcomes
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
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
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
Plasmatic concentrations of apoB100
Time frame: 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
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 3 Sep 2025.
- Results publication: PubMed 33228154Lamaziere A, Rainteau D, Kc P, Humbert L, Gauliard E, Ichou F, Ponnaiah M, Bouby N, Salem JE, Mallet JM, Guerin M, Lesnik P. Distinct Postprandial Bile Acids Responses to a High-Calorie Diet in Men Volunteers Underscore Metabolically Healthy and Unhealthy Phenotypes. Nutrients. 2020 Nov 19;12(11):3545. doi: 10.3390/nu12113545.
- Results publication: PubMed 32466286Motte AM, Gall JG, Salem JE, Dasque E, Lebot M, Frisdal E, Galier S, Villard EF, Bouaziz-Amar E, Lacorte JM, Charbit B, Le Goff W, Lesnik P, Guerin M. Reduced Reverse Cholesterol Transport Efficacy in Healthy Men with Undesirable Postprandial Triglyceride Response. Biomolecules. 2020 May 25;10(5):810. doi: 10.3390/biom10050810.
- Results publication: PubMed 39082393Galier S, Darabi M, Ma F, Materne C, Guillas I, Le Goff W, Kontush A, Guerin M. Reduced Capacity of High-Density Lipoprotein to Acquire Free Cholesterol From Triglyceride-Rich Lipoproteins Is Associated With Elevated Postprandial Hypertriglyceridemia in Healthy Men. J Am Heart Assoc. 2024 Aug 6;13(15):e034770. doi: 10.1161/JAHA.123.034770. Epub 2024 Jul 31.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Karim Ammour study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized meal in people with Healthy Volunteers, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 6 inclusion and 20 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Comparison of post-prandial HDL particles (time frame: before the meal (time = 0 hour) vs 2 hours after). 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 NCT03109067, which also lists 3 linked publications.
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 3 Sep 2025.