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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02177383
Other study ID # IB 994/08 PI
Secondary ID
Status Completed
Phase N/A
First received June 17, 2014
Last updated June 26, 2014
Start date September 2011

Study information

Verified date June 2014
Source University of the Balearic Islands
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

There are conflicting evidences of the effects of dietary supplementation with polyunsaturated fatty acids (PUFAs) on athletic performance. The described effects of PUFAs on the fat metabolism may be modulated by the expression and activity of transcription factor genes, suppressing or expressing genes associated with the synthesis and oxidation of fats and in oxidative stress and inflammation.

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.

In the field of professional sports and leisure use of food and / or antioxidants in the belief that these elements prevent muscle damage is very established. Most studies in athletes supplemented with antioxidant nutrients revealed no significant effects on physical performance, but it has shown that supplements protect against tissue damage induced by exercise. Recent studies have reported that over 35% of the Spanish people eat diets low or very low quality, which is clearly shown that over 10% of Spaniards have poor intakes (<2/3 IDR) riboflavin (men) , folate (women), vitamin C, vitamin A, vitamin D and vitamin E.

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. The aim of this study is to establish scientific basis for design functional foods improving athletic performance and health and avoiding the negative consequences of the oxidative damage induced by overexertion.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 16 Years to 35 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- Smokers

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Intervention

Dietary Supplement:
Docosahexaenoic acid diet supplementation
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.
Placebo supplementation
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.

Locations

Country Name City State
Spain University of Balearic Islands Palma de Mallorca Balearic Islands

Sponsors (2)

Lead Sponsor Collaborator
University of the Balearic Islands Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Capó 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 — View Citation

Martorell M, Capó 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 N — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary DHA on oxidative stress Effects of DHA diet supplementation, the training season and acute exercise on oxidative and nitrosative damage markers and antioxidant enzyme activities, and protein levels in different blood fractions. Baseline, week-8 (pre- and post-exercise) Yes
Secondary DHA on inflammation Effects of DHA diet supplementation, the training season and acute exercise on inflammation markers. Baseline, week-8 (pre- and post-exercise) Yes
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