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Completed

NCT Number: NCT04125199

Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage

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.

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Key information

Conditions

Sport

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

supplement consumption

Dietary 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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Changes in markers of muscle damage will be measured by serum lactate dehydrogenase (IU / L)

  2. 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.

    changes in markers of connective tissue injury: serum collagenase. They will be measured by blood extraction.

  3. 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.

    changes in the hematological profile. The samples are analyzed by the laboratory analyzer: BA 400 BioSystems

  4. 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.

    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.

  5. 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.

    change in the perception of fatigue

  6. 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.

    changes in the perception of muscle pain. Muscle pain will be measured from 0 (no pain), to 10 (unbearable pain).

  7. 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.

    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.

  8. Anthropometric variables

    Time frame: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.

    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).

  9. Impedancemetric variables

    Time frame: Two measurements. One, before the consumption of the product under study and another at 8 weeks of product consumption.

    fat mass, total water, lean mass (measured in%), muscle mass, bone mass (kg), basal metabolism (KJ).

  10. 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

    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)

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage Induced by Eccentric Exercise in Endurance Athletes

Acronym: (EDA)

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2019
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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