Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia
- Conditions
- Hyperlipemia
- Interventions
- Combination Product: Optimized BagelCombination Product: Conventional Bagel
- Registration Number
- NCT03950752
- Brief Summary
Postprandial lipemia produced by fat intake is a major risk factor for the development of cardiovascular diseases (CVD), the most important cause of disease and death in the Western world. Scientific evidence shows that the consumption of saturated fatty acids has a potential harmful effect on postprandial lipemia compared to the intake of monounsaturated fatty acids. The magnitude of postprandial lipemia is also determined by the health status of individuals, being altered in individuals with metabolic disorders associated with the development of CVD, such as hypertriglyceridemia.
Palm oil is widely used in bakery products because it is more economical compared to other fats and oils of other origin and for its stability properties that contribute to this type of food. This oil has a profile of fatty acids, rich in saturated fatty acids, mainly palmitic acid, which as mentioned above, is associated with health alterations. In addition, the investigators must add the environmental problems that are generated by the massive cultivation of the plant from which palm oil is extracted (oil palm Elaeis guineensis), including the loss of thousands of hectares of tropical forest and endangering to dozens of animal species from deforested areas.
The proliferation of all these arguments associated with the effect on the health and environment of the consumption of palm oil has given way to a paradigm shift in the use of palm oil in the food sector.
The hypothesis of the study is that consumption of bagels with a composition optimized in fatty acids, eliminating the content of palm oil and replacing it with high oleic sunflower oil and stearic acid completely hydrogenated without trans fatty acids, so that the same amount of fat is maintained, will decrease the postprandial lipemia, compared to the consumption of bagels with a more conventional composition in fatty acids, in healthy and / or with mild-moderate hypertriglyceridemia individuals.
The main objective of this study was to evaluate the effect of acute consumption of bagels without palm oil in its formulation and with an optimized fatty acid composition on postprandial lipemia measuring the evolution of plasma triglyceride levels in healthy and/or with mild-moderated hypertriglyceridemia individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bagels with optimized composition in fatty acids Optimized Bagel Participants will consume three bagels with an optimized composition in fatty acids and without oil palm in only one day. Bagels with conventional composition in fatty acids Conventional Bagel Participants will consume three bagels with a conventional composition in fatty acids in only one day.
- Primary Outcome Measures
Name Time Method Postprandial triglycerides levels Triglyceride levels in plasma will be determined before consuming bagels and after ingestion of bagels at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours at Visit 1 and Visit 2. Evolution of postprandial triglycerides levels in blood, assessed as area under the curve (AUC).
Serum triglycerides levels will be measured by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
- Secondary Outcome Measures
Name Time Method Evolution of postprandial glucose and insulin levels Glucose and insulin plasma levels will be determined before consuming bagels and at 30 minutes, 1 hour, 2 hours and 4 hours after the consumption of bagels at Visit 1 and Visit 2. Evolution of postprandial glucose and insulin levels in blood. It will be measured as AUC.
Serum glucose and insulin levels will be measured by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).Changes in endothelial function Endothelial function will be measured at 4 hours after the consumption of bagels at Visit 1 ad Visit 2. Measurement of the endothelial function using the Laser-Doppler technique.
Evolution of postprandial levels in blood of inflammation, thrombosis and oxidative stress markers in blood. IL-6, E-selectin, ICAM, VCAM, PA-1, Thrombomodulin and ORAC plasma levels will be determined before consuming bagels and at 4 hours and 6 hours after the consumption of bagels at Visit 1 and Visit 2. Evolution of the inflammation markers Interleukin 6 (IL-6), E-selectin, Intercellular adhesion molecule-1 (ICAM) and Vascular cellular adhesion molecule-1 (VCAM), the thrombosis markers Plasminogen activator 1 (PA-1) and Thrombomodulin, and the oxidative stress markers Oxygen Radical Absorbance Capacity (ORAC) and Malondialdehyde.
Serum parameters will be measured by human ELISA kits.Evolution of postprandial lipoprotein lipase activity in blood. LPL activity levels in plasma wil be measurd before consuming bagels and at 4 hours and 6 hours after the consumption of bagels at Visit 1 and Visit 2. Evolution of postprandial activity levels of lipoprotein lipase (LPL) in blood. It will measured by a fluorometric kit.
Serum activity of LPL will be measured by an fluorometric kit.Evolution of postprandial non-esterified fatty acids, total cholesterol, LDL and HDL cholesterol blood levels. Non-esterified fatty acids, total cholesterol, LDL and HDL cholesterol plasma levels will be determined before consuming bagels and at 1 hour, 2 hours, 4 hours and 6 hours after the consumption of bagels at Visit 1 and Visit 2. Evolution of non-esterified fatty acids, total cholesterol, LDL and HDL cholesterol in blood after the consumption of bagels.
Serum parameters will be measured by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).Evolution of postprandial Apolipoprotein (Apo) B-48, Apo B100 and Apo A1 in blood. Apo B48, Apo B100 and Apo A1 plasma levels will be determined before consuming bagels and at 4 hours and 6 hours after the consumption of bagels at Visit 1 and Visit 2. Evolution of Apo B48, Apo B100 and Apo A1 in blood after the consumption of bagels.
Apo B100 and Apo A1 in serum will be measured by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). Apo B48 in serum will be measured by an ELISA kit.Changes in blood pressure (measured in mmHg) Blood pressure will be measured before consuming bagels and at 4 hours after the consumption of bagels at Visit 1 and Visit 2. Systolic and diastolic blood pressure (SBP and DBP) will be measured twice after 2-5 minutes of patient respite, seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).
Fatty acid composition of postprandial serum triglycerides levels in blood. Fatty acid composition of serum triglycerides will be measured before consuming bagels and at 6 hours after the consumption of bagels at Visit 1 and Visit 2. Evaluation of fatty acid composition of serum triglycerides in blood. It will be measured by liquid chromatography coupled to mass spectrometry.
Trial Locations
- Locations (1)
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
🇪🇸Reus, Tarragona, Spain