Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners

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

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.

Study Overview

• Status: Completed
• Conditions: Immune Dysfunction
• Intervention / Treatment: Dietary supplement: dietary supplementation; Other: Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01506-000
    • Cruzeiro do Sul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Healthy recreational half-marathon runners.

Exclusion Criteria:

Auto-immune disease Inflammatory disease Cardiorespiratory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dietary supplementation; 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.	Dietary supplement: dietary supplementation; 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.
EXPERIMENTAL: Exercise; All volunteers performed two half-marathons. In the first half-marathon, all participants were not supplemented. In the second half-marathon, participants were supplemented. Blood samples were collected before and after both half-marathon race.	Dietary supplement: dietary supplementation; 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.; Other: Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil expression of ICAM-1, L-selectin, FasR and TRAIL	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).	Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of IL-1beta, IL-4, IL-6, IL-8, IL-10, and TNF-alpha.	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).	Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood leukocytes counts	Blood leukocyte counts in number of cells per mL was performed immediately after collection using routine automated system (hematological analysis cytochemic/isovolumetric assay).	Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Plasma LDH activity	Plasma lactate dehydrogenase (LDH) activity in U/L was immediately measured using an automated system (kinetic-enzymatic assay).	Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Tania C Pithon-Curi, PhD, University of Sao Paulo and Cruzeiro do Sul University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: dietary supplementation; inflammation; immune system; strenuous exercise; leucocyte function
• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: 979/2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO