HyperlipemiaPALMFREENCT03950752
Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia
A study testing Optimized Bagel and Conventional Bagel in people with Hyperlipemia, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipemia
- What is being tested?
- Optimized Bagel and Conventional Bagel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jun 2019to 8 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age.
- Sign the informed consent.
- Fasting serum triglyceride concentration < 150 mg/dL.
Who cannot join
- 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).
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- Being pregnant or intending to become pregnant.
- Be in breastfeeding period.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
- Inclusion Criteria mild-moderated hypertriglyceridemia population:
- Men and women over 18 years of age.
- Sign the informed consent.
- Fasting serum triglyceride concentration ≥ 150 mg/dL.
- Exclusion Criteria mild-moderated hypertriglyceridemia population:
- Having diabetes (glucose ≥ 126 mg/dL).
- Fasting serum triglyceride concentration > 880 mg/dL.
- History of pancreatitis.
- Serum LDL cholesterol levels > 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.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
Reus, Tarragona
About this study
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)
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.
Read more
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
- Being tested
- Optimized Bagel, Conventional Bagel
- Keywords
- postprandial, cardiovascular disease, saturated fatty acids, monounsaturated fatty acids, palm oil
- Medical subject headings
- Hyperlipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized BagelCombination 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.
Conventional BagelCombination 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Conventional Bagel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measurement of the endothelial function using the Laser-Doppler technique.
Measured: 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)
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).
Measured: 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
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).
Measured: 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.
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).
Measured: 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.
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.
Measured: 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 postprandial levels in blood of inflammation, thrombosis and oxidative stress markers in blood.
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.
Measured: 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 postprandial lipoprotein lipase activity in blood.
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.
Measured: 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.
Fatty acid composition of postprandial serum triglycerides levels in blood.
Evaluation of fatty acid composition of serum triglycerides in blood. It will be measured by liquid chromatography coupled to mass spectrometry.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start19 Jun 2019
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Eurecat, Europastry S.A., Hospital Universitari Sant Joan de Reus
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, Dr, Principal investigator, Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950752
- Sponsor's protocol ID
- PALMFREE
- Acronym
- PALMFREE
- Status last verified
- Mar 2022
- First submitted
- 9 May 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03950752
- Acronym / sponsor ID
- PALMFREE / PALMFREE
- Conditions
- Hyperlipemia
- Keywords
- postprandial, cardiovascular disease, saturated fatty acids, monounsaturated fatty acids, palm oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Collaborators
- Fundació Eurecat, Europastry S.A., Hospital Universitari Sant Joan de Reus
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bagels with optimized composition in fatty acids | Experimental | Combination Product: Optimized BagelParticipants will consume three bagels with an optimized composition in fatty acids and without oil palm in only one day. |
| Bagels with conventional composition in fatty acids | Active comparator | Combination Product: Conventional BagelParticipants will consume three bagels with a conventional composition in fatty acids in only one day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 18 years of age.
- Sign the informed consent.
- Fasting serum triglyceride concentration < 150 mg/dL.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized BagelParticipants 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. | Combination product | Bagels with optimized composition in fatty acids |
| Conventional BagelParticipants 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 | Combination product | Bagels with conventional composition in fatty acids |
Primary outcome
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).
8 secondary outcomes
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.
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.
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 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 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 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 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Solà, Dr principal investigator
Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized Bagel and Conventional Bagel in people with Hyperlipemia, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.