Sport(EDA)NCT04125199
Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage
A study testing supplement consumption in people with Sport, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized, placebo-controlled, double-blind, placebo-controlled clinical trial consisting of 15 triathletes in which it is intended to observe less inflammatory damage at the muscular level after performing eccentric exercises. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport
- What is being tested?
- supplement consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to 22 Dec 2016
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex.
- Age: between 18 and 45 years.
- BMI ≤ 35 Kg / m2.
- Volunteers capable of understanding the clinical study, competent to grant written informed consent and willing to comply with the study procedures and requirements.
- Subjects who do not suffer from chronic diseases.
- Non-smoking subjects or less than 10 cigarettes a day.
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- Subjects who have not consumed any type of NSAID within 48 hours prior to the study or during its development.
- Subjects without a history of administration of corticosteroids the previous month or during the study.
- Subjects without allergy to any of the products under investigation.
- Patients who have not modified their habits in the performance of physical activity during the study (injuries, injuries ...).
- Patients who have not modified their dietary habits during the previous month or intend to do so during the study.
Who cannot join
- Subjects who do not consume medication or nutritional supplements with antioxidant and / or anti-inflammatory properties.
- Subjects who do not consume diets with abundant antioxidant and / or anti-inflammatory products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage Induced by Eccentric Exercise in Endurance Athletes
Randomized, placebo-controlled, double-blind, placebo-controlled clinical trial consisting of 15 triathletes in which it is intended to observe less inflammatory damage at the muscular level after performing eccentric exercises.
- Conditions
- Sport
- Being tested
- supplement consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplement consumptionDietary supplement
Composition of the Experimental Product: Concentrated oil of Tridocosahexaenoin-AOX® * (350 mg per capsule), α-tocopherol and coating agent (gelatin). Each capsule is 700 mg, of which 500 mg is oil.
Placebo composition: Olive oil (each capsule is 700 mg).
Number of capsules: 6 per day, for any of the two products. The dose taken daily is 2.1 g / day for DHA.
Supplementation Period: Each group completed two 10-week consumption periods for each of the products, with an intermediate washing period of 4 weeks (28 days).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Dietary Supplement: supplement consumption |
| control group | Placebo comparator | Not described Receives: Dietary Supplement: supplement consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
Changes in the inflammatory marker: C-reactive protein (ml / dl). It is measured in venous blood by blood extraction.
Measured: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
Secondary outcomes (10)
muscle damage
Changes in markers of muscle damage will be measured by serum lactate dehydrogenase (IU / L)
Measured: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
connective tissue injury
changes in markers of connective tissue injury: serum collagenase. They will be measured by blood extraction.
Measured: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
Hematological variables: LEUCOCITS AND PLATES
changes in the hematological profile. The samples are analyzed by the laboratory analyzer: BA 400 BioSystems
Measured: It was measured before and after supplement consumption. In each of the times it was measured four times. 1: before performing the eccentric exercises, 2: just after, 3: at 24 hours after and 4: 48 hours later.
Biochemical variables
changes in lipid profile: : basal glycemia(mg/dl), lipid profile: total cholesterol (mg / dl), high density lipoprotein (mg / dl), low density lipoprotein (mg / dl), triglycerides (mg / dl), atherogenic index.
Measured: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
Variable for the evaluation of fatigue: Subjective perception test of Borg's effort
change in the perception of fatigue
Measured: at the end of the stress test with the multipower. It was measured three times. 1: at the end of the test, 2: at 24 hours, 3: at 48 hours.
Perception of pain through the analog visual scale.
changes in the perception of muscle pain. Muscle pain will be measured from 0 (no pain), to 10 (unbearable pain).
Measured: at the end of the stress test with the multipower. It was measured three times. 1: at the end of the test, 2: at 24 hours, 3: at 48 hours.
Isokinetic variables
changes in isokinetic variables: Peak torque, peak torque or force moment in extension and flexion in the different muscles involved and at the different measurement moments .It is measured in volts.
Measured: Twice. One, before the consumption of the product under study and another after the consumption of the product. It was measured after 10 weeks.
Anthropometric variables
Weight (Kg), size (cm), BMI kg / m2. Perimeters (measured in cm): (waist, hip, waist / hip index, relaxed biceps, contracted biceps, medial thigh, twin or calf).Folds (mm) (tricipítal, subscapular, suprailiac anterior or supraspinal, abdominal, quadricipital or thigh, leg or calf medial, bicipital, iliocrestal).
Diameters (cm) (radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol).
Measured: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.
Impedancemetric variables
fat mass, total water, lean mass (measured in%), muscle mass, bone mass (kg), basal metabolism (KJ).
Measured: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.
liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Measured: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later. One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Jan 2016
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SportStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125199
- Sponsor's protocol ID
- UCAMCFE-0009
- Acronym
- (EDA)
- Status last verified
- Oct 2019
- First submitted
- 5 Sep 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage Induced by Eccentric Exercise in Endurance Athletes
- ClinicalTrials.gov ID
- NCT04125199
- Acronym / sponsor ID
- (EDA) / UCAMCFE-0009
- Conditions
- Sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 14 Oct 2019 (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.
Randomized, placebo-controlled, double-blind, placebo-controlled clinical trial consisting of 15 triathletes in which it is intended to observe less inflammatory damage at the muscular level after performing eccentric exercises.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: supplement consumption |
| control group | Placebo comparator | Dietary Supplement: supplement consumption |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male sex.
- Age: between 18 and 45 years.
- BMI ≤ 35 Kg / m2.
- Volunteers capable of understanding the clinical study, competent to grant written informed consent and willing to comply with the study procedures and requirements.
- Subjects who do not suffer from chronic diseases.
Key exclusion criteria (2 listed)
- Subjects who do not consume medication or nutritional supplements with antioxidant and / or anti-inflammatory properties.
- Subjects who do not consume diets with abundant antioxidant and / or anti-inflammatory products.
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 |
|---|---|---|
| supplement consumptionComposition of the Experimental Product: Concentrated oil of Tridocosahexaenoin-AOX® * (350 mg per capsule), α-tocopherol and coating agent (gelatin). Each capsule is 700 mg, of which 500 mg is oil. Placebo composition: Olive oil (each capsule is 700 mg). Number of capsules: 6 per day, for any of the two products. The dose taken daily is 2.1 g / day for DHA. Supplementation Period: Each group completed two 10-week consumption periods for each of the products, with an intermediate washing period of 4 weeks (28 days). | Dietary supplement | control group, experimental group |
Primary outcome
Inflammatory markers
Time frame: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
Changes in the inflammatory marker: C-reactive protein (ml / dl). It is measured in venous blood by blood extraction.
10 secondary outcomes
muscle damage
Time frame: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
connective tissue injury
Time frame: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
Hematological variables: LEUCOCITS AND PLATES
Time frame: It was measured before and after supplement consumption. In each of the times it was measured four times. 1: before performing the eccentric exercises, 2: just after, 3: at 24 hours after and 4: 48 hours later.
Biochemical variables
Time frame: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.
Variable for the evaluation of fatigue: Subjective perception test of Borg's effort
Time frame: at the end of the stress test with the multipower. It was measured three times. 1: at the end of the test, 2: at 24 hours, 3: at 48 hours.
Perception of pain through the analog visual scale.
Time frame: at the end of the stress test with the multipower. It was measured three times. 1: at the end of the test, 2: at 24 hours, 3: at 48 hours.
Isokinetic variables
Time frame: Twice. One, before the consumption of the product under study and another after the consumption of the product. It was measured after 10 weeks.
Anthropometric variables
Time frame: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.
Impedancemetric variables
Time frame: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.
liver safety variables
Time frame: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later. One year
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 17 Oct 2019.
- 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.
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 supplement consumption in people with Sport, run by Universidad Católica San Antonio de Murcia 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 11 inclusion and 2 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 17 Oct 2019. 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?
Inflammatory markers (time frame: It was measured before and after consumption of the supplement. In each of the times it was measured four times. Before performing the eccentric exercises, just after, at 24 and 48 hours later.). 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 17 Oct 2019.