Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage

NCT04125199 | Completed DMC

• 1 other identifier: UCAMCFE-0009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sport

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• muscle damage

  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

  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

  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

  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

  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.

Study Arms (2)

experimental group

EXPERIMENTAL

Dietary Supplement: supplement consumption

control group

PLACEBO COMPARATOR

Dietary Supplement: supplement consumption

Interventions

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).

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: October 14, 2019
• Study Start: January 1, 2016
• Primary Completion: December 22, 2016
• Study Completion: December 22, 2016
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)