Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06731400

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Inar Castro Erger, Professor

CONTACT

[email protected]

+55(11)97429-3369

Vivian Massari Massari, Master

CONTACT

[email protected]

+55(11)96645-2370

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.