PerformanceMATCYNCT04128449
Modifications in the Anaerob Threshold in Cyclists by Consuming Docosahexaenoic Acid (DHA)
A study testing docosahexaenoic acid in people with Performance, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Performance
- What is being tested?
- docosahexaenoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 18 and 75 years old.
- Cyclists who train three or four times a week.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifications in the Anaerob Threshold in Cyclists (DHA)
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.
- Conditions
- Performance
- Being tested
- docosahexaenoic acid, Placebo
- Keywords
- performance, cyclists, docosahexaenoic acid, anaerobic threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docosahexaenoic acidDietary supplement
5 dragees every 24 hours
PlaceboDietary supplement
5 dragees every 24 hours
| Study group | Role | What they receive |
|---|---|---|
| docosahexaenoic acid | Experimental | 1,66 grams/24 hours (5 dragees) Receives: Dietary Supplement: docosahexaenoic acid |
| Placebo | Placebo comparator | sunflower oil (5 dragees) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ergospirometry variable: heart rate
It was done with a bicycle with electromagnetic resistance (Spin Trainer ;Technogym). Heart rate was measured in beats per minute.
Measured: 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
Measured: The change was evaluated after one month of consumption of the product
Secondary outcomes (3)
ergospirometry variable:respiratory ratio
It was done with a bicycle with electromagnetic resistance (Spin Trainer ;Technogym). Through the oxycon pro jaeger gas analyzer.
Measured: The change was evaluated after one month of consumption of the product
ergospirometry variable: oxygen equivalent
It was done with a bicycle with electromagnetic resistance (Spin Trainer ;Technogym). Through the oxycon pro jaeger gas analyzer.
Measured: The change was evaluated after one month of consumption of the product
blood variables: Natremia, potassium, chloremia, calcemia, , bicarbononatemia, ph, lactacidemia.
The following variables were analyzed: The variables are analyzed using the ABL 77 radiometer. The unit of measurement is mmol / L.
Measured: The change was evaluated after one month of product consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Apr 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128449
- Sponsor's protocol ID
- UCAMCFE-0004
- Acronym
- MATCY
- Status last verified
- Oct 2019
- First submitted
- 15 May 2018
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications in the Anaerob Threshold in Cyclists (DHA)
- ClinicalTrials.gov ID
- NCT04128449
- Acronym / sponsor ID
- MATCY / UCAMCFE-0004
- Conditions
- Performance
- Keywords
- performance, cyclists, docosahexaenoic acid, anaerobic threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| docosahexaenoic acid | Experimental | Dietary Supplement: docosahexaenoic acid1,66 grams/24 hours (5 dragees) |
| Placebo | Placebo comparator | Dietary Supplement: Placebosunflower oil (5 dragees) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male between 18 and 75 years old.
- Cyclists who train three or four times a week.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docosahexaenoic acid5 dragees every 24 hours | Dietary supplement | docosahexaenoic acid |
| Placebo5 dragees every 24 hours | Dietary supplement | Placebo |
Primary outcome
ergospirometry variable: heart rate
Time frame: The change was evaluated after one month of product consumption.
It was done with a bicycle with electromagnetic resistance (Spin Trainer ;Technogym). Heart rate was measured in beats per minute.
ergospirometry variable: absolute oxygen consumption
Time frame: The change was evaluated after one month of consumption of the product
It was done with a bicycle with electromagnetic resistance (Spin Trainer ;Technogym).It was measured in milliliters per minute
3 secondary outcomes
ergospirometry variable:respiratory ratio
Time frame: The change was evaluated after one month of consumption of the product
ergospirometry variable: oxygen equivalent
Time frame: The change was evaluated after one month of consumption of the product
blood variables: Natremia, potassium, chloremia, calcemia, , bicarbononatemia, ph, lactacidemia.
Time frame: The change was evaluated after one month of product consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing docosahexaenoic acid in people with Performance, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ergospirometry variable: heart rate (time frame: The change was evaluated after one month of product consumption.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.