An interventional study of Lipid Emulsion in Obesity, Metabolic Syndrome and Metabolism Disorder, sponsored by University of Seville. Active, not recruiting at 1 site in Spain. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-27.
Sponsored by University of Seville · Not applicable, Interventional, and Basic science
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Seville is the lead sponsor of 127 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Lipid Emulsion
Dietary Supplement: Lipid Emulsion
Dietary Supplement: Lipid Emulsion
Dietary Supplement: Lipid Emulsion
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.
Evolution of Glucose levels in postprandial state.
Blood glucose levels, measured by biochemical procedures (mg/dL).
Time frame: Up to 6 hours
Evolution of Insulin in postprandial state.
Blood Insulin levels, measured using ELISA procedures (pmol/L).
Time frame: Up to 6 hours
Evolution of C-peptide in postprandial state
C-peptide, using routine biochemical procedures (pmol/L).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 6 hours
This study is active, not recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Seville