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.
Condition or disease | Intervention/treatment | Phase |
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Hyperlipemia | Combination Product: Optimized Bagel Combination Product: Conventional Bagel | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia in Healthy or With Mild-Moderate Hypertriglyceridemia Subjects. Postprandial, Randomized, Controlled, Crossover and Double-Blind Study (PALMFREE) |
Estimated Study Start Date : | May 2019 |
Estimated Primary Completion Date : | July 2019 |
Estimated Study Completion Date : | September 2019 |
Arm | Intervention/treatment |
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Experimental: Bagels with optimized composition in fatty acids
Participants will consume three bagels with an optimized composition in fatty acids and without oil palm in only one day.
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Combination Product: Optimized Bagel
Participants will eat 132g of a bagel with an optimized composition in fatty acids in only one day, representing an ingestion of 556.5 kcal and 33g of total fat, of which 4.41g are saturated fatty acids, 24.27g are monounsaturated fatty acids, and 4.28g are polyunsaturated fatty acids.
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Active Comparator: Bagels with conventional composition in fatty acids
Participants will consume three bagels with a conventional composition in fatty acids in only one day.
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Combination Product: Conventional Bagel
Participants will eat 132g of a bagel with a conventional composition in fatty acids in only one day, representing an ingestion of 589.0 kcal and 35.6g of total fat, of which 16.76g are saturated fatty acids, 13.00g are monounsaturated fatty acids, and 5.81g are polyunsaturated fatty acids
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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).
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).
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 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.
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 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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria healthy population:
Exclusion Criteria healthy population:
Inclusion Criteria mild-moderated hypertriglyceridemia population:
Exclusion Criteria mild-moderated hypertriglyceridemia population:
Contact: Rosa M Valls, PhD | 0034 636944723 | estudis@ctns.cat | |
Contact: Anna Crescenti, PhD | +34977770958 | anna.crescenti@eurecat.org |
Spain | |
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus) | |
Reus, Tarragona, Spain |
Principal Investigator: | Rosa Solà, Dr | Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain. |
Tracking Information | |||||
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First Submitted Date ICMJE | May 9, 2019 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | May 15, 2019 | ||||
Estimated Study Start Date ICMJE | May 2019 | ||||
Estimated Primary Completion Date | July 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Postprandial triglycerides levels [ Time Frame: 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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia | ||||
Official Title ICMJE | Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia in Healthy or With Mild-Moderate Hypertriglyceridemia Subjects. Postprandial, Randomized, Controlled, Crossover and Double-Blind Study (PALMFREE) | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Hyperlipemia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
44 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 2019 | ||||
Estimated Primary Completion Date | July 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria healthy population:
Exclusion Criteria healthy population:
Inclusion Criteria mild-moderated hypertriglyceridemia population:
Exclusion Criteria mild-moderated hypertriglyceridemia population:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03950752 | ||||
Other Study ID Numbers ICMJE | PALMFREE | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Technological Centre of Nutrition and Health, Spain | ||||
Study Sponsor ICMJE | Technological Centre of Nutrition and Health, Spain | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Technological Centre of Nutrition and Health, Spain | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |