Clinical trial NCT04125199: Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage
Official title: Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage Induced by Eccentric Exercise in Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Inflammatory markers
timeFrame: 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:
measure: muscle damage
timeFrame: 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.
measure: connective tissue injury
timeFrame: 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.
measure: Hematological variables: LEUCOCITS AND PLATES
timeFrame: 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.
measure: Biochemical variables
timeFrame: 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.
measure: Variable for the evaluation of fatigue: Subjective perception test of Borg's effort
timeFrame: 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.
measure: Perception of pain through the analog visual scale.
timeFrame: 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.
measure: Isokinetic variables
timeFrame: Twice. One, before the consumption of the product under study and another after the consumption of the product. It was measured after 10 weeks.
measure: Anthropometric variables
timeFrame: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.
measure: Impedancemetric variables
timeFrame: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.
measure: liver safety variables
timeFrame: 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
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: