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

Technological Centre of Nutrition and Health, Spain

Status: Completed

Conditions: Hyperlipemia

Treatments: Combination Product: Conventional Bagel; Combination Product: Optimized Bagel

Study type: Interventional

Funder types: Other

Identifiers

NCT03950752

PALMFREE

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups

Bagels with optimized composition in fatty acids

Experimental group

Description:

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

Treatment:

Combination Product: Optimized Bagel

Bagels with conventional composition in fatty acids

Active Comparator group

Description:

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

Treatment:

Combination Product: Conventional Bagel