NCT02177383

Brief Summary

There are conflicting evidences of the effects of dietary supplementation with polyunsaturated fatty acids (PUFAs) on athletic performance. The investigators working hypothesis is based on the polyunsaturated fatty acids, given its pro-oxidative character and also by its action on transcription factors can modulate the antioxidant response and oxidative damage induced by physical activity.The overall objective of the study is to establish situations improving athletic performance and study the oxidative balance by manipulation of feeding patterns and consumption of nutritional supplements and investigate the involved mechanisms.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

June 17, 2014

Last Update Submit

June 26, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • DHA incorporation in erythrocyte cellular membranes

    Docosahexaenoic acid (DHA) is a conditionally essential fatty acid. Primary outcome: DHA incorporation in the erythrocyte cellular membranes by gas chromatography of soccer players during a training season

    Baseline, week 8

Secondary Outcomes (2)

  • DHA on oxidative stress

    Baseline, week-8 (pre- and post-exercise)

  • DHA on inflammation

    Baseline, week-8 (pre- and post-exercise)

Study Arms (2)

Docosahexaenoic acid

EXPERIMENTAL

1 liter/day of one experimental beverage (containing 0.2% olive oil + 0.6% DHA-S Martek) provides 1.14 g DHA/daily

Dietary Supplement: Docosahexaenoic acid diet supplementation

Olive oil

PLACEBO COMPARATOR

1 liter/day of placebo beverage (containing 0.8% olive oil)

Dietary Supplement: Placebo supplementation

Interventions

Nine soccer players (19 and 22 years old) took 1 liter/day of one experimental beverage (containing 0.2% olive oil + 0.6% DHA-S Martek). Follow-up 8 weeks. At week 8 an acute exercise season was programed. One blood sample was taken in resting conditions at beginning of the nutritional intervention (week 0, baseline). Another two blood samples were taken at the end of the nutritional intervention, in resting (week 8, pre-exercise) and post-exercise conditions (week 8, post-exercise). Biochemical measures, oxidative damage markers on lipids, proteins and DNA, antioxidant capabilities (enzyme activities and quantity of enzyme protein and gene expression) and inflammatory markers were measured in serum, plasma, erythrocytes, neutrophils and peripheral blood mononuclear cells.

Docosahexaenoic acid
Placebo supplementationDIETARY_SUPPLEMENT

Six professionals soccer players (19 and 22 years old) took 1 liter/day of placebo beverage (containing 0.8% olive oil). Follow-up 8 weeks. At week 8 an acute exercise season was programed. One blood sample was taken in resting conditions at beginning of the nutritional intervention (week 0, baseline). Another two blood samples were taken at the end of the nutritional intervention, in resting (week 8, pre-exercise) and post-exercise conditions (week 8, post-exercise). Biochemical measures, oxidative damage markers on lipids, proteins and DNA, antioxidant capabilities (enzyme activities and quantity of enzyme protein and gene expression) and inflammatory markers were measured in serum, plasma, erythrocytes, neutrophils and peripheral blood mononuclear cells.

Olive oil

Eligibility Criteria

Age16 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages eligible for study: 16 to 35 years
  • Genders eligible for study: Male
  • Equilibrate diet
  • Physical activity of 1-2 hours daily 5-7 days weekly.
  • Body mass index (19-25 kg/m2)

You may not qualify if:

  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Related Publications (3)

  • Capo X, Martorell M, Sureda A, Llompart I, Tur JA, Pons A. Diet supplementation with DHA-enriched food in football players during training season enhances the mitochondrial antioxidant capabilities in blood mononuclear cells. Eur J Nutr. 2015 Feb;54(1):35-49. doi: 10.1007/s00394-014-0683-2. Epub 2014 Mar 19.

  • Martorell M, Capo X, Sureda A, Tur JA, Pons A. Effects of docosahexaenoic acid diet supplementation, training, and acute exercise on oxidative balance in neutrophils. Appl Physiol Nutr Metab. 2014 Apr;39(4):446-57. doi: 10.1139/apnm-2013-0331. Epub 2013 Nov 4.

  • Capo X, Martorell M, Sureda A, Tur JA, Pons A. Effects of dietary Docosahexaenoic, training and acute exercise on lipid mediators. J Int Soc Sports Nutr. 2016 Apr 5;13:16. doi: 10.1186/s12970-016-0126-y. eCollection 2016.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 27, 2014

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations