An interventional study of dietary supplementation and Exercise in Immune Dysfunction, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other
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.
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.
427 studies on the registry are indexed under Immune System Diseases; 86 are open to participants now.
This study's enrollment of 46 is below the median of 66 across 317 interventional studies indexed under Immune System Diseases.
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Healthy recreational half-marathon runners.
Exclusion Criteria:
Auto-immune disease Inflammatory disease Cardiorespiratory disease
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
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 · Other: Exercise
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, all participants were supplemented. Blood samples were collected before and after both half-marathon race.
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).
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.
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).
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).
Time frame: 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).
Time frame: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Plan to share: No
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The record gives a start of Mar 2013, a primary completion of Sep 2014 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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