NCT03364699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

January 3, 2017

Last Update Submit

November 30, 2017

Conditions

Immune Dysfunction

Keywords

strenuous exercisedietary supplementationimmune systemleucocyte functioninflammation

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (1)

  • 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).

Other Outcomes (2)

  • Blood leukocytes counts

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

  • Plasma LDH activity

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

Study Arms (2)

dietary supplementation

ACTIVE COMPARATOR

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

Exercise

EXPERIMENTAL

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 supplementationOther: Exercise

Interventions

dietary supplementationDIETARY_SUPPLEMENT

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.

Exercisedietary supplementation
ExerciseOTHER

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.

Exercise

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy recreational half-marathon runners.

You may not qualify if:

  • Auto-immune disease Inflammatory disease Cardiorespiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cruzeiro do Sul University

São Paulo, 01506-000, Brazil

Location

MeSH Terms

Conditions

Immune System DiseasesInflammation

Interventions

Dietary SupplementsExercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tania C Pithon-Curi, PhD

    University of Sao Paulo and Cruzeiro do Sul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2017

First Posted

December 6, 2017

Study Start

March 1, 2013

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

December 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)