Clinical trial NCT03364699: Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners
Official title: High-EPA and High-DHA Fish Oils and Soybean Lecithin Modulate Inflammation and Neutrophil Properties in Runners Before and After a Half-marathon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Dysfunction
Keywords: strenuous exercise
dietary supplementation
immune system
leucocyte function
inflammation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2017-12-06
Enrollment: 46
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

Healthy recreational half-marathon runners.

Exclusion Criteria:

Auto-immune disease Inflammatory disease Cardiorespiratory disease

Primary outcomes:
measure: Neutrophil expression of ICAM-1, L-selectin, FasR and TRAIL
timeFrame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Secondary outcomes:
measure: Plasma concentrations of IL-1beta, IL-4, IL-6, IL-8, IL-10, and TNF-alpha.
timeFrame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Other outcomes:
measure: Blood leukocytes counts
timeFrame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
measure: Plasma LDH activity
timeFrame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Locations:
city: Sao Paulo
country: Brazil
facility: Cruzeiro do Sul University
Study officials:
affiliation: University of Sao Paulo and Cruzeiro do Sul University
name: Tania C Pithon-Curi, PhD
role: PRINCIPAL_INVESTIGATOR
References: