Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage

NCT ID: NCT04125199

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-12-22

Brief Summary

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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.

Detailed Description

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Conditions

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Sport

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group

Group Type EXPERIMENTAL

supplement consumption

Intervention Type 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

Group Type PLACEBO_COMPARATOR

supplement consumption

Intervention Type 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).

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier López Román

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Murcia

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UCAMCFE-0009

Identifier Type: -

Identifier Source: org_study_id

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