ObesityNCT05746013
Lipoproteins and ImmunoMetabolism
A study testing Lipid Emulsion in people with Obesity and Metabolic Syndrome, run by University of Seville at 1 site in Spain.
Trial summary
Dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and cardiovascular diseases (CVD). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome, Metabolism Disorder
- What is being tested?
- Lipid Emulsion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2020to Dec 2025
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of metabolic syndrome
Who cannot join
- Allergy to dairy products
- Allergy to fish oil
- Vegetarian
- Tobacco smoker
- Current or recent (<4 wk) use of fish oil supplements or more than four times fish/week
- Received innoculations within 2 mo of starting the study or planned to during the study
Show all 15Show fewer
- Donated or intended to donate blood from 2 mo before the study till 2 mo after the study
- Unstable body weight (no weight gain/loss >3 kg)
- Medical condition that can interfere with the study outcome (i.e., biochemical evidence of active heart disease, renal impairment, hypothyroidism, liver dysfunction, etc.)
- Use of medications know to interfere with glucose homeostasis or lipid metabolism
- Use of anti-inflammatory medication, hormone or cytokine or growth factor therapies
- Abuse of drugs and/or alcohol
- Participation in another biomedical study within 1 mo before the first screening visit, or not wanting to be informed about chance-findings during screening.
- Severe diabetes, which requires application of insuin
- Diabetes-related complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deciphering the Role of Dietary Fatty Acids on HDL Functionality
Dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and cardiovascular diseases (CVD). Excessive consumption of fats enriched in saturated fatty acids (SFA) is associated with an increased risk of atherosclerosis and other CVD. By contrast, replacement of SFA with monounsaturated fatty acids (MUFA) and omega-3 long-chain polyunsaturated fatty acids (ω-3 PUFA) has been reported to be inversely associated with risk of atherosclerosis. This is partly due to the ability of MUFA (and PUFA) in modulating low-density lipoprotein (LDL) and triglyceride-rich lipoprotein (TRL) lipid composition and oxidation status, and thereby the functionality of such lipoproteins. While most of the nutritional studies have focused on elucidating the mechanisms by which dietary fats affect LDL and TRL, little or nothing is known about the regulatory effect of MUFA and PUFA on structure and functional remodelling of high-density lipoproteins (HDL). There is clear evidence of an inverse association between plasma levels of HDL and the formation of atherosclerotic plaques. However, recent studies have suggested that HDL may not be as beneficial as thought at least in patients with established cardiometabolic disorders. In those patients, the HDL behaves as pro-inflammatory lipoproteins. Until now, few studies have addressed this "dark side" of HDL and has never been evaluated the role of dietary fatty acids on HDL plasticity (i.e. phenotype and functionality). A better understanding of this duality between anti-inflammatory and pro-inflammatory HDL would be relevant to prevent HDL-related atherogenic dyslipidemias and to provide personalized dietary advices for a successful management of atherogenic lipid profiles. This step of proof-of-principle will determine the instrumental role of major fatty acids present on a diet (SFA, MUFA and MUFA plus ω-3 PUFA) in promoting or reversing the phenotype of pro-inflammatory HDL. We expect to offer a novel insight on HDL and its relationship with dietary fatty acids through the following objectives: 1) To analyse acute changes in the lipidome, proteome and functional properties of HDL in humans (healthy volunteers and patients with metabolic syndrome) upon a challenge of a meal rich in SFA, MUFA or MUFA plus ω-3 PUFA; and 2) To analyse the influence of diets rich in SFA, MUFA and MUFA plus ω-3 PUFA on HDL plasticity in a preclinical animal model of diet-induced metabolic syndrome and that develops atherosclerosis.
- Conditions
- Obesity, Metabolic Syndrome, Metabolism Disorder, Inflammation, Immune System and Related Disorders
- Being tested
- Lipid Emulsion
- Medical subject headings
- Obesity, Metabolic Syndrome, Metabolic Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid EmulsionDietary supplement
The oral lipid emulsions will contain water, sucrose, emulsifier, flavouring, and the corresponding fat (50 g/m2 of body surface area): milk cream (SFA) or refined olive oil (MUFA) with or without a dose of omega-3 PUFA, which will consist of 920 mg of EPA and 760 mg of DHA.
| Study group | Role | What they receive |
|---|---|---|
| No Fat meal | Placebo comparator | Not described Receives: Dietary Supplement: Lipid Emulsion |
| SFA meal | Experimental | Not described Receives: Dietary Supplement: Lipid Emulsion |
| MUFA meal | Experimental | Not described Receives: Dietary Supplement: Lipid Emulsion |
| PUFA meal | Experimental | Not described Receives: Dietary Supplement: Lipid Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Glucose levels in postprandial state.
Blood glucose levels, measured by biochemical procedures (mg/dL).
Measured: Up to 6 hours
Evolution of Insulin in postprandial state.
Blood Insulin levels, measured using ELISA procedures (pmol/L).
Measured: Up to 6 hours
Evolution of C-peptide in postprandial state
C-peptide, using routine biochemical procedures (pmol/L).
Measured: Up to 6 hours
Evolution of Trigliceride and NEFA parameters in postprandial state
Triglyceride and NEFA levels in plasma will be measured at several time-points postprandially using routine biochemical procedures (mg/dL)
Measured: Up to 6 hours
Evolution of NAMPT in postprandial state
NAMP activity will be measured in plasma at several postprandial time-points using colorimetric techniques (UI/ml).
Measured: Up to 6 hours
Evolution of cytokines in postprandial state
Pro-inflammatory and anti-inflammatory cytokines, including NFα, IL-1β, IL-6, IL-8, IL-10, ICAM-1, MCP-1, leptin, and adiponectin, in plasma will be measured using ELISA techniques (mg/dl).
Measured: Up to 6 hours
Evolution of inflammatory markers in postprandial state.
The acute phase protein (hsCRP), PAI-1, fibrinogen, transferrin, albumin, and myeloperoxidase (MPO) will be measured using colorimetric techniques (mg/dl).
Measured: Up to 6 hours
HDL lipoproteome
HDL protein and lipid fractions HDL will be analysed by MALDI-TOF MS after employing an organic polymeric anion exchanger [Poly(GMA/EGDMA)] for lipoprotein enrichment from serum samples.
Measured: Up to 6 hours.
HDL antioxidant capacity
HDL obtained from different postprandial points will be tested by their capacity to prevent LDL oxidation with an in vitro cell-free assay.
Measured: Up to 6 hours.
HDL cholesterol efflux capacity
HDL cholesterol efflux capacity will be measured using fluorescent-labelled cholesterol. HDL extracted from serum at different postprandial points will be tested.
Measured: Up to 6 hours.
HDL LCAT activity
Lecithin choltesteryl acyl transferase (LCAT) activity (UI/ml) of HDL obtained from different postprandial points will be measured using a fluorimetric cell-free assay.
Measured: Up to 6 hours.
HDL PON1 activity
Paraoxonse 1 (PON1) activity, of HDL obtained from serum at different postprandial tiems, will be measured using a colorimetric assay (pmol/mL).
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Feb 2020
- Primary completionMay 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish National Research Council
- Responsible party
- Principal investigator, Sergio Montserrat de la Paz, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746013
- Sponsor's protocol ID
- US-1263458
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Role of Dietary Fatty Acids on HDL Functionality
- ClinicalTrials.gov ID
- NCT05746013
- Acronym / sponsor ID
- US-1263458
- Conditions
- Obesity, Metabolic Syndrome, Metabolism Disorder, Inflammation, Immune System and Related Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Spanish National Research Council
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Feb 2023 (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.
Dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and cardiovascular diseases (CVD). Excessive consumption of fats enriched in saturated fatty acids (SFA) is associated with an increased risk of atherosclerosis and other CVD. By contrast, replacement of SFA with monounsaturated fatty acids (MUFA) and omega-3 long-chain polyunsaturated fatty acids (ω-3 PUFA) has been reported to be inversely associated with risk of atherosclerosis. This is partly due to the ability of MUFA (and PUFA) in modulating low-density lipoprotein (LDL) and triglyceride-rich lipoprotein (TRL) lipid composition and oxidation status, and thereby the functionality of such lipoproteins. While most of the nutritional studies have focused on elucidating the mechanisms by which dietary fats affect LDL and TRL, little or nothing is known about the regulatory effect of MUFA and PUFA on structure and functional remodelling of high-density lipoproteins (HDL). There is clear evidence of an inverse association between plasma levels of HDL and the formation of atherosclerotic plaques. However, recent studies have suggested that HDL may not be as beneficial as thought at least in patients with established cardiometabolic disorders. In those patients, the HDL behaves as pro-inflammatory lipoproteins. Until now, few studies have addressed this "dark side" of HDL and has never been evaluated the role of dietary fatty acids on HDL plasticity (i.e. phenotype and functionality). A better understanding of this duality between anti-inflammatory and pro-inflammatory HDL would be relevant to prevent HDL-related atherogenic dyslipidemias and to provide personalized dietary advices for a successful management of atherogenic lipid profiles. This step of proof-of-principle will determine the instrumental role of major fatty acids present on a diet (SFA, MUFA and MUFA plus ω-3 PUFA) in promoting or reversing the phenotype of pro-inflammatory HDL. We expect to offer a novel insight on HDL and its relationship with dietary fatty acids through the following objectives: 1) To analyse acute changes in the lipidome, proteome and functional properties of HDL in humans (healthy volunteers and patients with metabolic syndrome) upon a challenge of a meal rich in SFA, MUFA or MUFA plus ω-3 PUFA; and 2) To analyse the influence of diets rich in SFA, MUFA and MUFA plus ω-3 PUFA on HDL plasticity in a preclinical animal model of diet-induced metabolic syndrome and that develops atherosclerosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Fat meal | Placebo comparator | Dietary Supplement: Lipid Emulsion |
| SFA meal | Experimental | Dietary Supplement: Lipid Emulsion |
| MUFA meal | Experimental | Dietary Supplement: Lipid Emulsion |
| PUFA meal | Experimental | Dietary Supplement: Lipid Emulsion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of metabolic syndrome
Key exclusion criteria (15 listed)
- Allergy to dairy products
- Allergy to fish oil
- Vegetarian
- Tobacco smoker
- Current or recent (<4 wk) use of fish oil supplements or more than four times fish/week
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 |
|---|---|---|
| Lipid EmulsionThe oral lipid emulsions will contain water, sucrose, emulsifier, flavouring, and the corresponding fat (50 g/m2 of body surface area): milk cream (SFA) or refined olive oil (MUFA) with or without a dose of omega-3 PUFA, which will consist of 920 mg of EPA and 760 mg of DHA. | Dietary supplement | MUFA meal, No Fat meal, PUFA meal, SFA meal |
Primary outcome
Evolution of Glucose levels in postprandial state.
Time frame: Up to 6 hours
Blood glucose levels, measured by biochemical procedures (mg/dL).
Evolution of Insulin in postprandial state.
Time frame: Up to 6 hours
Blood Insulin levels, measured using ELISA procedures (pmol/L).
Evolution of C-peptide in postprandial state
Time frame: Up to 6 hours
C-peptide, using routine biochemical procedures (pmol/L).
Evolution of Trigliceride and NEFA parameters in postprandial state
Time frame: Up to 6 hours
Triglyceride and NEFA levels in plasma will be measured at several time-points postprandially using routine biochemical procedures (mg/dL)
Evolution of NAMPT in postprandial state
Time frame: Up to 6 hours
NAMP activity will be measured in plasma at several postprandial time-points using colorimetric techniques (UI/ml).
Evolution of cytokines in postprandial state
Time frame: Up to 6 hours
Pro-inflammatory and anti-inflammatory cytokines, including NFα, IL-1β, IL-6, IL-8, IL-10, ICAM-1, MCP-1, leptin, and adiponectin, in plasma will be measured using ELISA techniques (mg/dl).
Evolution of inflammatory markers in postprandial state.
Time frame: Up to 6 hours
The acute phase protein (hsCRP), PAI-1, fibrinogen, transferrin, albumin, and myeloperoxidase (MPO) will be measured using colorimetric techniques (mg/dl).
HDL lipoproteome
Time frame: Up to 6 hours.
HDL protein and lipid fractions HDL will be analysed by MALDI-TOF MS after employing an organic polymeric anion exchanger [Poly(GMA/EGDMA)] for lipoprotein enrichment from serum samples.
HDL antioxidant capacity
Time frame: Up to 6 hours.
HDL obtained from different postprandial points will be tested by their capacity to prevent LDL oxidation with an in vitro cell-free assay.
HDL cholesterol efflux capacity
Time frame: Up to 6 hours.
HDL cholesterol efflux capacity will be measured using fluorescent-labelled cholesterol. HDL extracted from serum at different postprandial points will be tested.
HDL LCAT activity
Time frame: Up to 6 hours.
Lecithin choltesteryl acyl transferase (LCAT) activity (UI/ml) of HDL obtained from different postprandial points will be measured using a fluorimetric cell-free assay.
HDL PON1 activity
Time frame: Up to 6 hours
Paraoxonse 1 (PON1) activity, of HDL obtained from serum at different postprandial tiems, will be measured using a colorimetric assay (pmol/mL).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid Emulsion in people with Obesity and Metabolic Syndrome, run by University of Seville at 1 site in Spain.
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 1 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Evolution of Glucose levels in postprandial state. (time frame: Up to 6 hours). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2023.