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

Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners



Sponsors


Source

University of Sao Paulo

Oversight Info

Has Dmc

Yes


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.

Overall Status

Completed

Start Date

2013-03-01

Completion Date

2015-03-01

Primary Completion Date

2014-09-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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

Secondary Outcome

Measure

Time Frame

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

Enrollment

46

Condition


Intervention

Intervention Type

Dietary Supplement

Intervention Name


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 Group Label

dietary supplementation

Exercise



Intervention Type

Other

Intervention Name


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.

Arm Group Label

Exercise



Eligibility

Criteria

Inclusion Criteria:

Healthy recreational half-marathon runners.

Exclusion Criteria:

Auto-immune disease Inflammatory disease Cardiorespiratory disease

Gender

Male

Minimum Age

20 Years

Maximum Age

45 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Tania C Pithon-Curi, PhD
Principal Investigator
University of Sao Paulo and Cruzeiro do Sul University

Location

Facility

Cruzeiro do Sul University
Sao Paulo 01506-000 Brazil

Location Countries

Country

Brazil


Verification Date

2017-11-01

Lastchanged Date

2017-11-30

Firstreceived Date

2017-01-03

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Sao Paulo

Investigator Full Name

Tania Cristina Pithon-Curi

Investigator Title

Principal Investigator


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

dietary supplementation

Arm Group Type

Active Comparator

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 Group Label

Exercise

Arm Group Type

Experimental

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.



Firstreceived Results Date

N/A

Other Outcome

Measure

Blood leukocytes counts

Time Frame

Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

Description

Blood leukocyte counts in number of cells per mL was performed immediately after collection using routine automated system (hematological analysis cytochemic/isovolumetric assay).


Measure

Plasma LDH activity

Time Frame

Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).

Description

Plasma lactate dehydrogenase (LDH) activity in U/L was immediately measured using an automated system (kinetic-enzymatic assay).



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Other

Masking

Double (Participant, Investigator)


Study First Submitted

January 3, 2017

Study First Submitted Qc

November 30, 2017

Study First Posted

December 6, 2017

Last Update Submitted

November 30, 2017

Last Update Submitted Qc

November 30, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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