Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage ((EDA))

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.

Study Overview

• Status: Completed
• Conditions: Sport
• Intervention / Treatment: Dietary supplement: supplement consumption

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Dietary supplement: supplement consumption; 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).
Placebo Comparator: control group	Dietary supplement: supplement consumption; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	Changes in the inflammatory marker: C-reactive protein (ml / dl). It is measured in venous blood by blood extraction.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle damage	Changes in markers of muscle damage will be measured by serum lactate dehydrogenase (IU / L)	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.	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	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.	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	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).	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.	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).	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).	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)	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

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No