Oxidative StressNCT02177383
Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance
A study testing Docosahexaenoic acid diet supplementation in people with Oxidative Stress and Exercise, run by University of the Balearic Islands at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 16 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Exercise, Training Season
- What is being tested?
- Docosahexaenoic acid diet supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Dec 2011
- 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 16 to 35 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Smokers
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official title: Scientific Basis of the Action of Foods Rich in Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance
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.
Read the detailed 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.
- Conditions
- Oxidative Stress, Exercise, Training Season, Antioxidant Capabilities, Athletic Performance
- Being tested
- Docosahexaenoic acid diet supplementation, Placebo supplementation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid diet supplementationDietary supplement
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Docosahexaenoic acid diet supplementation |
| Olive oil | Placebo comparator | 1 liter/day of placebo beverage (containing 0.8% olive oil) Receives: Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, week 8
Secondary outcomes (2)
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.
Measured: Baseline, week-8 (pre- and post-exercise)
DHA on inflammation
Effects of DHA diet supplementation, the training season and acute exercise on inflammation markers.
Measured: Baseline, week-8 (pre- and post-exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startSep 2011
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Antoni Pons, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177383
- Sponsor's protocol ID
- IB 994/08 PI
- Status last verified
- Jun 2014
- First submitted
- 17 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
Publications
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.
PubMed 24643755Martorell 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.
PubMed 24669986Capo 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.
PubMed 27051354
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Basis of the Action of Foods Rich in Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance
- ClinicalTrials.gov ID
- NCT02177383
- Acronym / sponsor ID
- IB 994/08 PI
- Conditions
- Oxidative Stress, Exercise, Training Season, Antioxidant Capabilities, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosahexaenoic acid | Experimental | Dietary Supplement: Docosahexaenoic acid diet supplementation1 liter/day of one experimental beverage (containing 0.2% olive oil + 0.6% DHA-S Martek) provides 1.14 g DHA/daily |
| Olive oil | Placebo comparator | Dietary Supplement: Placebo supplementation1 liter/day of placebo beverage (containing 0.8% olive oil) |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Smokers
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 |
|---|---|---|
| Docosahexaenoic acid diet supplementationNine 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. | Dietary supplement | Docosahexaenoic acid |
| Placebo supplementationSix 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. | Dietary supplement | Olive oil |
Primary outcome
DHA incorporation in erythrocyte cellular membranes
Time frame: Baseline, week 8
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
2 secondary outcomes
DHA on oxidative stress
Time frame: Baseline, week-8 (pre- and post-exercise)
DHA on inflammation
Time frame: Baseline, week-8 (pre- and post-exercise)
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 27 Jun 2014.
- Results publication: PubMed 24643755Capo 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.
- Results publication: PubMed 24669986Martorell 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.
- Derived from this study: PubMed 27051354Capo 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexaenoic acid diet supplementation in people with Oxidative Stress and Exercise, run by University of the Balearic Islands at 1 site in Spain.
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 5 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 27 Jun 2014. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
DHA incorporation in erythrocyte cellular membranes (time frame: Baseline, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02177383, which also lists 3 linked publications.
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 27 Jun 2014.