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Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners

Primary Purpose

Immune Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
dietary supplementation
Exercise
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Immune Dysfunction focused on measuring strenuous exercise, dietary supplementation, immune system, leucocyte function, inflammation

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy recreational half-marathon runners.

Exclusion Criteria:

Auto-immune disease Inflammatory disease Cardiorespiratory disease

Sites / Locations

  • Cruzeiro do Sul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

dietary supplementation

Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
January 3, 2017
Last Updated
November 30, 2017
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
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1. Study Identification

Unique Protocol Identification Number
NCT03364699
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Dysfunction
Keywords
strenuous exercise, dietary supplementation, immune system, leucocyte function, inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dietary supplementation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplementation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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 Outcome Measure Information:
Title
Neutrophil expression of ICAM-1, L-selectin, FasR and TRAIL
Description
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).
Time Frame
Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Secondary Outcome Measure Information:
Title
Plasma concentrations of IL-1beta, IL-4, IL-6, IL-8, IL-10, and TNF-alpha.
Description
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).
Time Frame
Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Other Pre-specified Outcome Measures:
Title
Blood leukocytes counts
Description
Blood leukocyte counts in number of cells per mL was performed immediately after collection using routine automated system (hematological analysis cytochemic/isovolumetric assay).
Time Frame
Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Title
Plasma LDH activity
Description
Plasma lactate dehydrogenase (LDH) activity in U/L was immediately measured using an automated system (kinetic-enzymatic assay).
Time Frame
Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy recreational half-marathon runners. Exclusion Criteria: Auto-immune disease Inflammatory disease Cardiorespiratory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania C Pithon-Curi, PhD
Organizational Affiliation
University of Sao Paulo and Cruzeiro do Sul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cruzeiro do Sul University
City
Sao Paulo
ZIP/Postal Code
01506-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners

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