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Completed

NCT Number: NCT03364699

Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners

The purpose of this study was evaluate the comparative effects of FO rich in EPA (FO-EPA) and FO rich in DHA (FO-DHA) on inflammation and neutrophil properties after a prolonged and strenuous exercise. The effect of soybean lecithin on the same parameters and conditions also was evaluated.

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Key information

Conditions

Immune Dysfunction Immune System Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cruzeiro do Sul University

São Paulo, 01506-000, Brazil

About this study

The volunteers were not taking any medication during the study. All individuals signed an informed consent form to the study protocol. Both experimental procedure and informed consent form of this study were in accordance with Guide for the Care and Use of Humans.

All volunteers performed two half-marathons. In the first half-marathon, all participants were not supplemented. Dietary supplementation was initiated immediately after the first race. The volunteers were randomly separated into 3 groups: Soybean lecithin group; Fish oil-DHA group and Fish oil-EPA group. The volunteers ingested 3 g daily of SL or FO-DHA containing 1.5 g DHA and 0.3 g EPA or FO-EPA containing 1.6 g EPA and 0.3 g DHA (EPA:DHA = 5.4:1) during 60 days.

Experimental design:

First race - not supplemented, blood samples were collected before (Phase I) and immediately after race (Phase II).

Second race - dietary supplemented, blood samples were collected before (Phase III) and immediately after the race (Phase IV).

Results were analyzed by two-way analysis of variance (two-way ANOVA) and Tukey post-hoc test. The statistical analysis of the half-marathon effect was performed using nonparametric t tests. Results were considered statistically significant for P<0.05.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy recreational half-marathon runners.

Exclusion criteria

Auto-immune disease Inflammatory disease Cardiorespiratory disease

Treatment and study plan

Dietary supplementation

Dietary Supplement

The volunteers ingested 3 g daily of Soybean lecithin or fish oil rich in docosa-hexanoic acid (DHA) containing 1.5 g DHA and 0.3 g EPA (DHA:EPA = 5:1) or fish oil rich in eicosapentaenoic acid (EPA) containing 1.6 g EPA and 0.3 g DHA (EPA:DHA = 5.4:1) during 60 days.

Exercise

Other

All volunteers performed two half-marathons. In the first half-marathon, all participants were not supplemented. In the second half-marathon, all participants were supplemented. Blood samples were collected before and after both half-marathon race.

Primary outcomes

  1. Neutrophil expression of ICAM-1, L-selectin, FasR and TRAIL

    Time frame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

    Neutrophil expression was expressed in fluorescence intensity evaluated by flow cytometry at 530/30 nm (FITC) 660/20 nm (APC) or 695/40 nm (PE) wavelengths (BD Accuri cytometer).

Secondary outcomes

  1. Plasma concentrations of IL-1beta, IL-4, IL-6, IL-8, IL-10, and TNF-alpha.

    Time frame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

    Plasma concentrations of IL-1beta, IL-4, IL-6, IL-8, IL-10, and TNF-alpha in pg/mL were measured by Millipore® Multiplex Assays Using Luminex® (Millipore Corp., MA).

Other outcomes

  1. Blood leukocytes counts

    Time frame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

    Blood leukocyte counts in number of cells per mL was performed immediately after collection using routine automated system (hematological analysis cytochemic/isovolumetric assay).

  2. Plasma LDH activity

    Time frame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

    Plasma lactate dehydrogenase (LDH) activity in U/L was immediately measured using an automated system (kinetic-enzymatic assay).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

High-EPA and High-DHA Fish Oils and Soybean Lecithin Modulate Inflammation and Neutrophil Properties in Runners Before and After a Half-marathon

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 6, 2017
Registry last updated
Dec 6, 2017

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

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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.

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