Atherosclerosis Cardiovascular DiseaseNCT06731400
Variability in Human Fatty Acids Profiles Based on Blood Fractions and Metabolic Conditions
A study testing EPA supplementation in people with Atherosclerosis Cardiovascular Disease, run by University of Sao Paulo.
Trial summary
Fatty acids play a crucial role in various metabolic pathways, with their proportions and distributions across different cells and tissues influenced by diet and metabolism. In addition to providing energy through oxidative reactions, fatty acids serve as substrates for the synthesis of numerous molecules involved in… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Atherosclerosis Cardiovascular Disease
- What is being tested?
- EPA supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals of both sexes
- Aged between 20 and 50 years
- No contraindications for the use of fish oil supplements
Who cannot join
- Use of medications or supplements to reduce triacylglycerols;
- Consumption of fish oil or other supplements/medicines rich in n-3 or n-6 PUFA in the month before the test;
- Consumption of fatty fish (salmon, herring, mackerel, white tuna or sardines) more than twice a month in the month before the test;
- Refusal to avoid PUFA supplements and seafood during the study period;
- Severe heart failure;
- Severe active liver disease;
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- Planned coronary intervention or surgery,
- History of acute or chronic pancreatitis;
- Hypersensitivity to fish, shellfish or capsule ingredients;
- Autoimmune diseases requiring immunosuppressive therapy;
- Current corticosteroid use systemic,
- Neoplasms;
- Chemotherapy or radiotherapy within the past 12 months (patients who have undergone curative surgery without requiring additional treatment within the past year may be included);
- Inflammatory bowel disease;
- Chronic diarrhea;
- Significant non-transient hematological abnormalities;
- Kidney dysfunction;
- Severe liver disease;
- Inability to provide informed record;
- Participation in another clinical trial with an experimental agent in the last 90 days;
- Malabsorption syndrome;
- Recent drug or alcohol abuse;
- Atrial fibrillation;
- Bleeding disorders.
- Pregnancy
- Breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Fatty acids play a crucial role in various metabolic pathways, with their proportions and distributions across different cells and tissues influenced by diet and metabolism. In addition to providing energy through oxidative reactions, fatty acids serve as substrates for the synthesis of numerous molecules involved in cellular signaling processes. Therefore, quantifying fatty acids in biological samples is essential for ensuring the quality of clinical trials involving lipids and for understanding the relationship between fats and health conditions. However, the fatty acid profiles reported in clinical trials can exhibit significant heterogeneity due to both endogenous and exogenous factors, including the metabolic condition of the patients and the specific blood fraction analyzed. This variability makes difficult the comparison of results across studies. Moreover, despite the crucial role of fatty acids in immune response, most results are derived from erythrocytes, plasma, or serum, providing limited information on their variability in leukocytes. Thus, the hypothesis of this study is that metabolic conditions, characterized by fasting or postprandial states, can influence the fatty acid profile depending on the blood fraction analyzed. To evaluate this hypothesis, six healthy individuals will be supplemented with fish oil for eight weeks, with blood samples collected before and after the intervention. Fatty acid levels will be measured using gas chromatography coupled with mass spectrometry in total plasma, phospholipids, erythrocytes, and leukocytes. The results will help estimate the variability caused by metabolic states according to the blood fraction, which is critical when conducting clinical trials in patients where fasting cannot be assured and is essential for comparing fatty acid profiles in studies involving leukocytes.
Read the detailed description
In summary, it is known that numerous factors can interfere with the effects of administering polyunsaturated fatty acids (n-3 PUFA), including aspects related to the experimental design, such as the form and dosage used, the duration of treatments, the blood fraction and the metabolic state of the individuals. In this context, given the importance of precise quantification of fatty acids in biological samples obtained from humans, the present study will aim to evaluate the variability caused by the administration of fish oil before and after 8 weeks of supplementation. This will involve comparing the fatty acid profiles according to different fractions (plasma, leukocytes, and erythrocytes) and fasting conditions (fasting or post-prandial). In plasma, the analysis will also consider both the total sample and the phospholipidic fraction.
- Conditions
- Atherosclerosis Cardiovascular Disease
- Being tested
- EPA supplementation
- Keywords
- EPA, DHA, supplementation, leukocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA supplementationDietary supplement
Six healthy individuals will be supplemented with fish oil contains omega 3 (EPA) for eight weeks, with blood samples collected before and after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| EPA Suplementation | Experimental | Six healthy individuals will be supplemented with fish oil for eight weeks, with blood samples collected before and after the intervention. Receives: Dietary Supplement: EPA supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fasting or postprandial states on the fatty acid profile
This study will assess whether fasting or postprandial states affect the fatty acid profile based on the blood fraction analyzed. Six healthy individuals will be supplemented with 2 g/day of fish oil for eight weeks, with blood samples collected before and after the intervention. Fatty acid levels will be measured using gas chromatography-mass spectrometry in total plasma, phospholipids, erythrocytes, and leukocytes.
Measured: From December 2024 to February 2025
The fasting or postprandial states on the fatty acid profile
Fatty acid levels will be measured in total plasma, phospholipids, erythrocytes, and leukocytes by fasting or postprandial states.
Measured: From December 2024 to February 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start3 Dec 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inar Castro Erger, University of Sao Paulo
- Investigators
- Inar Castro Erger, Professor, Principal investigator, Faculty of Pharmaceutical Sciences at the University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731400
- Sponsor's protocol ID
- 82746224.7.0000.0067
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lozier BK, Kim RN, Zuromski LM, Kish-Trier E, De Biase I, Yuzyuk T. Effect of fasting status and other pre-analytical variables on quantitation of long-chain fatty acids in red blood cells. Prostaglandins Leukot Essent Fatty Acids. 2020 Dec;163:102211. doi: 10.1016/j.plefa.2020.102211. Epub 2020 Nov 19.
PubMed 33249349BLIGH EG, DYER WJ. A rapid method of total lipid extraction and purification. Can J Biochem Physiol. 1959 Aug;37(8):911-7. doi: 10.1139/o59-099. No abstract available.
PubMed 13671378Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
PubMed 30415628
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability in Human Fatty Acids Profiles Based on Blood Fractions and Metabolic Conditions
- ClinicalTrials.gov ID
- NCT06731400
- Acronym / sponsor ID
- 82746224.7.0000.0067
- Conditions
- Atherosclerosis Cardiovascular Disease
- Keywords
- EPA, DHA, supplementation, leukocytes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 3 Dec 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 12 Dec 2024 (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.
Fatty acids play a crucial role in various metabolic pathways, with their proportions and distributions across different cells and tissues influenced by diet and metabolism. In addition to providing energy through oxidative reactions, fatty acids serve as substrates for the synthesis of numerous molecules involved in cellular signaling processes. Therefore, quantifying fatty acids in biological samples is essential for ensuring the quality of clinical trials involving lipids and for understanding the relationship between fats and health conditions. However, the fatty acid profiles reported in clinical trials can exhibit significant heterogeneity due to both endogenous and exogenous factors, including the metabolic condition of the patients and the specific blood fraction analyzed. This variability makes difficult the comparison of results across studies. Moreover, despite the crucial role of fatty acids in immune response, most results are derived from erythrocytes, plasma, or serum, providing limited information on their variability in leukocytes. Thus, the hypothesis of this study is that metabolic conditions, characterized by fasting or postprandial states, can influence the fatty acid profile depending on the blood fraction analyzed. To evaluate this hypothesis, six healthy individuals will be supplemented with fish oil for eight weeks, with blood samples collected before and after the intervention. Fatty acid levels will be measured using gas chromatography coupled with mass spectrometry in total plasma, phospholipids, erythrocytes, and leukocytes. The results will help estimate the variability caused by metabolic states according to the blood fraction, which is critical when conducting clinical trials in patients where fasting cannot be assured and is essential for comparing fatty acid profiles in studies involving leukocytes.
Detailed description
In summary, it is known that numerous factors can interfere with the effects of administering polyunsaturated fatty acids (n-3 PUFA), including aspects related to the experimental design, such as the form and dosage used, the duration of treatments, the blood fraction and the metabolic state of the individuals. In this context, given the importance of precise quantification of fatty acids in biological samples obtained from humans, the present study will aim to evaluate the variability caused by the administration of fish oil before and after 8 weeks of supplementation. This will involve comparing the fatty acid profiles according to different fractions (plasma, leukocytes, and erythrocytes) and fasting conditions (fasting or post-prandial). In plasma, the analysis will also consider both the total sample and the phospholipidic fraction.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPA Suplementation | Experimental | Dietary Supplement: EPA supplementationSix healthy individuals will be supplemented with fish oil for eight weeks, with blood samples collected before and after the intervention. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals of both sexes
- Aged between 20 and 50 years
- No contraindications for the use of fish oil supplements
Key exclusion criteria (26 listed)
- Use of medications or supplements to reduce triacylglycerols;
- Consumption of fish oil or other supplements/medicines rich in n-3 or n-6 PUFA in the month before the test;
- Consumption of fatty fish (salmon, herring, mackerel, white tuna or sardines) more than twice a month in the month before the test;
- Refusal to avoid PUFA supplements and seafood during the study period;
- Severe heart failure;
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 |
|---|---|---|
| EPA supplementationSix healthy individuals will be supplemented with fish oil contains omega 3 (EPA) for eight weeks, with blood samples collected before and after the intervention. | Dietary supplement | EPA Suplementation |
Primary outcome
The fasting or postprandial states on the fatty acid profile
Time frame: From December 2024 to February 2025
This study will assess whether fasting or postprandial states affect the fatty acid profile based on the blood fraction analyzed. Six healthy individuals will be supplemented with 2 g/day of fish oil for eight weeks, with blood samples collected before and after the intervention. Fatty acid levels will be measured using gas chromatography-mass spectrometry in total plasma, phospholipids, erythrocytes, and leukocytes.
The fasting or postprandial states on the fatty acid profile
Time frame: From December 2024 to February 2025
Fatty acid levels will be measured in total plasma, phospholipids, erythrocytes, and leukocytes by fasting or postprandial states.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 33249349Lozier BK, Kim RN, Zuromski LM, Kish-Trier E, De Biase I, Yuzyuk T. Effect of fasting status and other pre-analytical variables on quantitation of long-chain fatty acids in red blood cells. Prostaglandins Leukot Essent Fatty Acids. 2020 Dec;163:102211. doi: 10.1016/j.plefa.2020.102211. Epub 2020 Nov 19.
- Background: PubMed 13671378BLIGH EG, DYER WJ. A rapid method of total lipid extraction and purification. Can J Biochem Physiol. 1959 Aug;37(8):911-7. doi: 10.1139/o59-099. No abstract available.
- Background: PubMed 30415628Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
- 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.
Inar Castro Erger, Professor principal investigator
Faculty of Pharmaceutical Sciences at the University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing EPA supplementation in people with Atherosclerosis Cardiovascular Disease, run by University of Sao Paulo.
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 26 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: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inar Castro Erger, Professor (+55(11)97429-3369, inar@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fasting or postprandial states on the fatty acid profile (time frame: From December 2024 to February 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06731400, which also lists 3 linked publications.
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 12 Dec 2024.