NCT04128449

Brief Summary

In a double-blind, parallel randomized clinical trial with 38 cyclists in whom the performance improvement was determined after the consumption of docosahexaenoic acid for one month.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

May 15, 2018

Last Update Submit

October 16, 2019

Conditions

Keywords

performancecyclistsdocosahexaenoic acidanaerobic threshold

Outcome Measures

Primary Outcomes (2)

  • ergospirometry variable: heart rate

    It was done with a bicycle with electromagnetic resistance (Spin Trainer ;Technogym). Heart rate was measured in beats per minute.

    The change was evaluated after one month of product consumption.

  • ergospirometry variable: absolute oxygen consumption

    It was done with a bicycle with electromagnetic resistance (Spin Trainer ;Technogym).It was measured in milliliters per minute

    The change was evaluated after one month of consumption of the product

Secondary Outcomes (3)

  • ergospirometry variable:respiratory ratio

    The change was evaluated after one month of consumption of the product

  • ergospirometry variable: oxygen equivalent

    The change was evaluated after one month of consumption of the product

  • blood variables: Natremia, potassium, chloremia, calcemia, , bicarbononatemia, ph, lactacidemia.

    The change was evaluated after one month of product consumption.

Study Arms (2)

docosahexaenoic acid

EXPERIMENTAL

1,66 grams/24 hours (5 dragees)

Dietary Supplement: docosahexaenoic acid

Placebo

PLACEBO COMPARATOR

sunflower oil (5 dragees)

Dietary Supplement: Placebo

Interventions

docosahexaenoic acidDIETARY_SUPPLEMENT

5 dragees every 24 hours

docosahexaenoic acid
PlaceboDIETARY_SUPPLEMENT

5 dragees every 24 hours

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male between 18 and 75 years old.
  • Cyclists who train three or four times a week.

You may not qualify if:

  • Suffering some type of chronic disease.
  • Consume habitually pharmacological treatments that could influence the physiological or biochemical responses to be analyzed in the present work.
  • Consumption in the month prior to the start of the study, or during the performance of the same, functional food enriched with omega-3 fatty acids.
  • To present during the performance of the stress tests, any of the absolute or relative contraindications dictated by the American College of Sports Medicine (ACSM, 1999) 15 would be duly informed and excluded from the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

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

Study Record Dates

First Submitted

May 15, 2018

First Posted

October 16, 2019

Study Start

April 1, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

October 18, 2019

Record last verified: 2019-10

Locations