Variability in Human Fatty Acids Profiles Based on Blood Fractions and Metabolic Conditions

NCT06731400 | Not Yet Recruiting DMC

• 1 other identifier: 82746224.7.0000.0067
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Atherosclerosis Cardiovascular Disease

Keywords

EPA; DHA; supplementation; leukocytes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From December 2024 to February 2025

Study Arms (1)

EPA Suplementation

EXPERIMENTAL

Six healthy individuals will be supplemented with fish oil for eight weeks, with blood samples collected before and after the intervention.

Dietary Supplement: EPA supplementation

Interventions

EPA supplementation DIETARY_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.

EPA Suplementation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals of both sexes
• Aged between 20 and 50 years
• No contraindications for the use of fish oil supplements

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (3)

• 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.

  PMID: 33249349 BACKGROUND

• BLIGH 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.

  PMID: 13671378 BACKGROUND

• Bhatt 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.

  PMID: 30415628 BACKGROUND

Study Officials

• Inar Castro Erger, Professor

  Faculty of Pharmaceutical Sciences at the University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inar Castro Erger, Professor

CONTACT

+55(11)97429-3369; inar@usp.br

Vivian Massari Massari, Master

CONTACT

+55(11)96645-2370; vivianmoura@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 12, 2024
• Study Start: December 3, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share