Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia

NCT03950752 | Completed

• 1 other identifier: PALMFREE
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipemia

Keywords

postprandial; cardiovascular disease; saturated fatty acids; monounsaturated fatty acids; palm oil

Outcome Measures

Primary Outcomes (1)

• Postprandial triglycerides levels

  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).

  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.

Secondary Outcomes (8)

• Changes in endothelial function

  Endothelial function will be measured at 4 hours after the consumption of bagels at Visit 1 ad Visit 2.

• 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.

• 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 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 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.

Study Arms (2)

Bagels with optimized composition in fatty acids

EXPERIMENTAL

Participants will consume three bagels with an optimized composition in fatty acids and without oil palm in only one day.

Combination Product: Optimized Bagel

Bagels with conventional composition in fatty acids

ACTIVE COMPARATOR

Participants will consume three bagels with a conventional composition in fatty acids in only one day.

Combination Product: Conventional Bagel

Interventions

Optimized Bagel COMBINATION_PRODUCT

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.

Bagels with optimized composition in fatty acids

Conventional Bagel COMBINATION_PRODUCT

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

Bagels with conventional composition in fatty acids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Having diabetes (glucose ≥ 126 mg/dL).
• BMI values \<18 kg/m\^2 o \>25 kg/m\^2.
• Waist circumference \> 150 cm.
• Present dyslipidemia (LDL cholesterol \> 189 mg/dL).
• Present celiac disease or food allergies related to the study product.
• Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
• Being pregnant or intending to become pregnant.
• Be in breastfeeding period.
• Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
• Men and women over 18 years of age.
• Sign the informed consent.
• Fasting serum triglyceride concentration ≥ 150 mg/dL.
• Having diabetes (glucose ≥ 126 mg/dL).
• Fasting serum triglyceride concentration \> 880 mg/dL.
• History of pancreatitis.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead
• Fundació Eurecat: collaborator
• Europastry S.A.: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator

Study Sites (1)

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.
• Europastry S.A.

MeSH Terms

Conditions

Hyperlipidemias; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rosa Solà, Dr

  Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 15, 2019
• Study Start: June 19, 2019
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)