Immune DysfunctionNCT03364699
Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners
A study testing dietary supplementation and Exercise in people with Immune Dysfunction, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immune Dysfunction
- What is being tested?
- dietary supplementation and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy recreational half-marathon runners.
Who cannot join
- Auto-immune disease Inflammatory disease Cardiorespiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Immune Dysfunction
- Being tested
- dietary supplementation, Exercise
- Keywords
- strenuous exercise, dietary supplementation, immune system, leucocyte function, inflammation
- Medical subject headings
- Immune System Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: dietary supplementation; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: Immediately after the first race (Phase II) and immediately after the second race in supplemented athletes (Phase IV).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startMar 2013
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Tania Cristina Pithon-Curi, University of Sao Paulo
- Investigators
- Tania C Pithon-Curi, PhD, Principal investigator, University of Sao Paulo and Cruzeiro do Sul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364699
- Sponsor's protocol ID
- 979/2010
- Status last verified
- Nov 2017
- First submitted
- 3 Jan 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03364699
- Acronym / sponsor ID
- 979/2010
- Conditions
- Immune Dysfunction
- Keywords
- strenuous exercise, dietary supplementation, immune system, leucocyte function, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- 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
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary supplementation | Active comparator | Dietary Supplement: dietary supplementationThe 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. |
| Exercise | Experimental | Dietary Supplement: dietary supplementation, Other: ExerciseAll 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy recreational half-marathon runners.
Key exclusion criteria (1 listed)
- Auto-immune disease Inflammatory disease Cardiorespiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplementationThe 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 | Exercise, dietary supplementation |
| ExerciseAll 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. | Other | Exercise |
Primary outcome
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania C Pithon-Curi, PhD principal investigator
University of Sao Paulo and Cruzeiro do Sul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplementation and Exercise in people with Immune Dysfunction, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.