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Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03364699
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):
Tania Cristina Pithon-Curi, University of Sao Paulo
  Purpose
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.

Condition Intervention
Immune Dysfunction Dietary Supplement: dietary supplementation Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by Tania Cristina Pithon-Curi, University of Sao Paulo:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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).

  • 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).


Enrollment: 46
Study Start Date: March 2013
Study Completion Date: March 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy recreational half-marathon runners.

Exclusion Criteria:

Auto-immune disease Inflammatory disease Cardiorespiratory disease

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364699


Locations
Brazil
Cruzeiro do Sul University
Sao Paulo, Brazil, 01506-000
Sponsors and Collaborators
University of Sao Paulo
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
  More Information

Responsible Party: Tania Cristina Pithon-Curi, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03364699     History of Changes
Other Study ID Numbers: 979/2010
First Submitted: January 3, 2017
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tania Cristina Pithon-Curi, University of Sao Paulo:
strenuous exercise
dietary supplementation
immune system
leucocyte function
inflammation

Additional relevant MeSH terms:
Immune System Diseases