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Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia (PALMFREE)

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ClinicalTrials.gov Identifier: NCT03950752
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Eurecat
Europastry S.A.
Hospital Universitari Sant Joan de Reus
Information provided by (Responsible Party):
Technological Centre of Nutrition and Health, Spain

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.


Condition or disease Intervention/treatment Phase
Hyperlipemia Combination Product: Optimized Bagel Combination Product: Conventional Bagel Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Palm oil

Arm Intervention/treatment
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.
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.

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.
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




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. Changes in endothelial function [ Time Frame: 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.

  2. Changes in blood pressure (measured in mmHg) [ Time Frame: 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).

  3. Evolution of postprandial glucose and insulin levels [ Time Frame: 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).


  4. Evolution of postprandial non-esterified fatty acids, total cholesterol, LDL and HDL cholesterol blood levels. [ Time Frame: 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).


  5. Evolution of postprandial Apolipoprotein (Apo) B-48, Apo B100 and Apo A1 in blood. [ Time Frame: 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.


  6. Evolution of postprandial levels in blood of inflammation, thrombosis and oxidative stress markers in blood. [ Time Frame: 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.


  7. Evolution of postprandial lipoprotein lipase activity in blood. [ Time Frame: 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.


  8. Fatty acid composition of postprandial serum triglycerides levels in blood. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria healthy population:

  1. Men and women over 18 years of age.
  2. Sign the informed consent.
  3. Fasting serum triglyceride concentration < 150 mg/dL.

Exclusion Criteria healthy population:

  1. Having diabetes (glucose ≥ 126 mg/dL).
  2. BMI values <18 kg/m^2 o >25 kg/m^2.
  3. Waist circumference > 150 cm.
  4. Present dyslipidemia (LDL cholesterol > 189 mg/dL).
  5. Present celiac disease or food allergies related to the study product.
  6. Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
  7. Being pregnant or intending to become pregnant.
  8. Be in breastfeeding period.
  9. Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
  10. Follow a hypocaloric diet and/or pharmacological treatment for weight loss.

Inclusion Criteria mild-moderated hypertriglyceridemia population:

  1. Men and women over 18 years of age.
  2. Sign the informed consent.
  3. Fasting serum triglyceride concentration ≥ 150 mg/dL.

Exclusion Criteria mild-moderated hypertriglyceridemia population:

  1. Having diabetes (glucose ≥ 126 mg/dL).
  2. Fasting serum triglyceride concentration > 880 mg/dL.
  3. History of pancreatitis.
  4. Serum LDL cholesterol levels > 189 mg/dL).
  5. Present celiac disease or food allergies related to the study product.
  6. Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
  7. Being pregnant or intending to become pregnant.
  8. Be in breastfeeding period.
  9. Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
  10. Follow a hypocaloric diet and/or pharmacological treatment for weight loss.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950752


Contacts
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Contact: Rosa M Valls, PhD 0034 636944723 estudis@ctns.cat
Contact: Anna Crescenti, PhD +34977770958 anna.crescenti@eurecat.org

Locations
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Spain
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
Reus, Tarragona, Spain
Sponsors and Collaborators
Technological Centre of Nutrition and Health, Spain
Eurecat
Europastry S.A.
Hospital Universitari Sant Joan de Reus
Investigators
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Principal Investigator: Rosa Solà, Dr Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.

Additional Information:
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Responsible Party: Technological Centre of Nutrition and Health, Spain
ClinicalTrials.gov Identifier: NCT03950752     History of Changes
Other Study ID Numbers: PALMFREE
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Technological Centre of Nutrition and Health, Spain:
postprandial
cardiovascular disease
saturated fatty acids
monounsaturated fatty acids
palm oil

Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases