Clinical trial NCT03950752: Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipemia
Keywords: postprandial
cardiovascular disease
saturated fatty acids
monounsaturated fatty acids
palm oil
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
Collaborators: name: Fundació Eurecat
name: Europastry S.A.
name: Hospital Universitari Sant Joan de Reus
First posted: 2019-05-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Postprandial triglycerides levels
timeFrame: 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:
measure: Changes in endothelial function
timeFrame: Endothelial function will be measured at 4 hours after the consumption of bagels at Visit 1 ad Visit 2.
measure: Changes in blood pressure (measured in mmHg)
timeFrame: Blood pressure will be measured before consuming bagels and at 4 hours after the consumption of bagels at Visit 1 and Visit 2.
measure: Evolution of postprandial glucose and insulin levels
timeFrame: 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.
measure: Evolution of postprandial non-esterified fatty acids, total cholesterol, LDL and HDL cholesterol blood levels.
timeFrame: 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.
measure: Evolution of postprandial Apolipoprotein (Apo) B-48, Apo B100 and Apo A1 in blood.
timeFrame: 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.
measure: Evolution of postprandial levels in blood of inflammation, thrombosis and oxidative stress markers in blood.
timeFrame: 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.
measure: Evolution of postprandial lipoprotein lipase activity in blood.
timeFrame: 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.
measure: Fatty acid composition of postprandial serum triglycerides levels in blood.
timeFrame: 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.
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
state: Tarragona
Study officials:
affiliation: Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.
name: Rosa Solà, Dr
role: PRINCIPAL_INVESTIGATOR
References: