Healthy AthletesPhase 4NCT03915535
Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold
A Phase 4 study testing Eicosapentaenoic acid + Docosahexaenoic acid and Eicosapentaenoic acid in people with Healthy Athletes, run by Samuel Fortin at 1 site in Canada.
Trial summary
he objective of this study is to compare the effects two different formulations of fish oil monoglycerides on the mitochondrial functions and on the lactate threshold of athletes during a high intensity exercise. Twenty four (24) subjects will be enrolled in the study and followed for a period of 90 days. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Athletes
- What is being tested?
- Eicosapentaenoic acid + Docosahexaenoic acid and Eicosapentaenoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2019to 28 Mar 2022
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant aged of at least 19 years old.
- Availability for the entire duration of the study and willingness to participate based on the information provided in the Informed Consent Form (ICF) duly read and signed by the latter.
- Participant with no intellectual problems that may limit the validity of consent to participate in the study or the compliance with the protocol requirements, ability to cooperate adequately, to understand and to observe the instructions of the physician or designee.
- Participant having no difficulty swallowing tablets or capsules.
- Participant who engages in at least six hours of physical activity (intense sport training) per week.
Who cannot join
- Allergy to fish or history of allergic reactions attributable to fish or to a fish oil-like compound.
- Female who are pregnant or are lactating.
- Intake of omega-3 monoglycerides in the 30 days prior to day 1 of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Two Formulations of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold in Athletes. A Pilot Study
he objective of this study is to compare the effects two different formulations of fish oil monoglycerides on the mitochondrial functions and on the lactate threshold of athletes during a high intensity exercise. Twenty four (24) subjects will be enrolled in the study and followed for a period of 90 days. A first visit will capture all the baseline parameters and will be followed by two subsequent visits (at day 45 and at day 90) where the same measurements will be done. The subjects will be divided in two parallel groups. Subjects of group A will receive a constant daily dose of 4,3g eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) whereas subjects of group B will receive a constant daily dose of 4,4g of EPA only. Subjects will be treated from day 1 to day 90 without interruption or modification to their regimen.
Read the detailed description
Twenty four (24) subjects will be enrolled and sequentially assigned to one of the two parallel treatment formulations. The study population will be men and women of 19 years and older with no allergy or history of allergy to fish. Participants must practice at least 6 hours of intense physical activity per week as a life habit and must not have taken omega-3 monoglycerides within the last 30 day prior to study enrollment. Pregnant or lactating women will be excluded from the study.
The objective of this study is to compare the effects of MaxSimil, a combination of EPA and DHA monoglycerides with the monoglyceride EPA alone (MAG-EPA). For each group, the primary objectives will be to measure the changes in mitochondrial functions (LEAK, RCR and OKPHOS) and in the lactate threshold of athletes throughout the study. The program is similar for each visit and contains: fasting bood draw, standardized breakfast, health questionnaire, vital signs and the lactate threshold test. The latter consists of a standardized exercise on a stationary bike during which the blood lactate concentration as well as blood sugar concentration will be monitored by capillary puncture at determined time intervals. The fasting blood draw will be used for the analysis of mitochondrial functions, the omega-3 index as well as the quantification of cytokines such as Interleukine-1, Interleukine-6 and the C-reactive protein (CRP). All the data collected after 45 and 90 days will be compared to the baseline measurements.
The screening tasks include pregnancy testing for women, collection of demographic information and baseline health/ life habits questionnaire.
Study Medication will be dispensed to subjects at visit 1. Medication will be self-administered by the subjects at home. Subjects will be given a diary to fill-out in case of missed doses, concomitant medication intake, adverse events or significant changes in life habits.
- Conditions
- Healthy Athletes
- Being tested
- Eicosapentaenoic acid + Docosahexaenoic acid, Eicosapentaenoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic acid + Docosahexaenoic acidDietary supplement
Also called MaxSimil
Monoglyceride Omega-3 fish oils
Eicosapentaenoic acidDietary supplement
Also called MAG-EPA
Monoglyceride Omega-3 fish oil
| Study group | Role | What they receive |
|---|---|---|
| MaxSimil | Active comparator | Subjects of group A will receive a constant daily dose of 4.3g of MaxSimil, a combination of EPA + DHA in proportions of 500/200, for a period of 90 days. Receives: Dietary Supplement: Eicosapentaenoic acid + Docosahexaenoic acid |
| MAG-EPA | Experimental | Subjects of group B will receive a constant daily dose of 4.4g of MAG-EPA, a purified formulation of EPA with traces of DHA (730/050), for a period of 90 days. Receives: Dietary Supplement: Eicosapentaenoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of mitochondrial functions (Oxphos. Leak, RCR)
For both group, mitochondrial functions will be measured at baseline, after 45 days and after 90 days of treatment. Potential improvement will be compared between groups
Measured: 90 days per subject. About seven months for the whole study.
Measurement of the improvement of the Lactate threshold in athletes
For both group, lactate threshold will be measured at baseline, after 45 days and after 90 days of treatment. Potential improvement will be compared between groups
Measured: 90 days per subject. About seven months for the whole study.
Secondary outcomes (3)
Quantification of inflammation markers (Cytokines)
At each visit ( V1 = baseline, V2 = day 45, V3 = day 90), a blood sample will be taken to quantify the following cytokines: Interleukine-1, Interleukine-6 and C-reactive Protein. Inflammation markers such as cytokines might be indicators of good responders to Omega-3 treatments \& prevention.
Measured: 90 days per subject. About seven months for the whole study.
measurement of the Omega-3 index
At each visit ( V1 = baseline, V2 = day 45, V3 = day 90), a blood sample will be taken to measure the omega-3 index (total amount of EPA + DHA in the red blood cells). This parameter helps to monitor the subject's exposition to treatment.
Measured: 90 days per subject. About seven months for the whole study.
Recording and monitoring of life habits
At each visit ( V1 = baseline, V2 = day 45, V3 = day 90), subjects will be questioned about their life habits such as: smoking, alcohol intake, number of fish meals per week, sports habits, vitamins and dietary supplements intake. These informations should help to control bias in primary objectives response and give further hints to what makes good responders.
Measured: 90 days per subject. About seven months for the whole study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start19 Sep 2019
- Primary completion18 Dec 2019
- Study completion28 Mar 2022
Why it stopped: Several impacts of COVID-19 on recruitment and organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AthletesStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a two parallel groups study without randomisation.12 subjects will be enrolled in group A. Afterwards, the remaining 12 subjects will be enrolled in group B.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Fortin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Samuel Fortin, SCF Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915535
- Sponsor's protocol ID
- PSP-MG01
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Formulations of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold in Athletes. A Pilot Study
- ClinicalTrials.gov ID
- NCT03915535
- Acronym / sponsor ID
- PSP-MG01
- Conditions
- Healthy Athletes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Several impacts of COVID-19 on recruitment and organization
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Samuel FortinIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 16 Apr 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.
he objective of this study is to compare the effects two different formulations of fish oil monoglycerides on the mitochondrial functions and on the lactate threshold of athletes during a high intensity exercise. Twenty four (24) subjects will be enrolled in the study and followed for a period of 90 days. A first visit will capture all the baseline parameters and will be followed by two subsequent visits (at day 45 and at day 90) where the same measurements will be done. The subjects will be divided in two parallel groups. Subjects of group A will receive a constant daily dose of 4,3g eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) whereas subjects of group B will receive a constant daily dose of 4,4g of EPA only. Subjects will be treated from day 1 to day 90 without interruption or modification to their regimen.
Detailed description
Twenty four (24) subjects will be enrolled and sequentially assigned to one of the two parallel treatment formulations. The study population will be men and women of 19 years and older with no allergy or history of allergy to fish. Participants must practice at least 6 hours of intense physical activity per week as a life habit and must not have taken omega-3 monoglycerides within the last 30 day prior to study enrollment. Pregnant or lactating women will be excluded from the study.
The objective of this study is to compare the effects of MaxSimil, a combination of EPA and DHA monoglycerides with the monoglyceride EPA alone (MAG-EPA). For each group, the primary objectives will be to measure the changes in mitochondrial functions (LEAK, RCR and OKPHOS) and in the lactate threshold of athletes throughout the study. The program is similar for each visit and contains: fasting bood draw, standardized breakfast, health questionnaire, vital signs and the lactate threshold test. The latter consists of a standardized exercise on a stationary bike during which the blood lactate concentration as well as blood sugar concentration will be monitored by capillary puncture at determined time intervals. The fasting blood draw will be used for the analysis of mitochondrial functions, the omega-3 index as well as the quantification of cytokines such as Interleukine-1, Interleukine-6 and the C-reactive protein (CRP). All the data collected after 45 and 90 days will be compared to the baseline measurements.
The screening tasks include pregnancy testing for women, collection of demographic information and baseline health/ life habits questionnaire.
Study Medication will be dispensed to subjects at visit 1. Medication will be self-administered by the subjects at home. Subjects will be given a diary to fill-out in case of missed doses, concomitant medication intake, adverse events or significant changes in life habits.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two parallel groups study without randomisation.12 subjects will be enrolled in group A. Afterwards, the remaining 12 subjects will be enrolled in group B.
| Arm | Type | Receives |
|---|---|---|
| MaxSimil | Active comparator | Dietary Supplement: Eicosapentaenoic acid + Docosahexaenoic acidSubjects of group A will receive a constant daily dose of 4.3g of MaxSimil, a combination of EPA + DHA in proportions of 500/200, for a period of 90 days. |
| MAG-EPA | Experimental | Dietary Supplement: Eicosapentaenoic acidSubjects of group B will receive a constant daily dose of 4.4g of MAG-EPA, a purified formulation of EPA with traces of DHA (730/050), for a period of 90 days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant aged of at least 19 years old.
- Availability for the entire duration of the study and willingness to participate based on the information provided in the Informed Consent Form (ICF) duly read and signed by the latter.
- Participant with no intellectual problems that may limit the validity of consent to participate in the study or the compliance with the protocol requirements, ability to cooperate adequately, to understand and to observe the instructions of the physician or designee.
- Participant having no difficulty swallowing tablets or capsules.
- Participant who engages in at least six hours of physical activity (intense sport training) per week.
Key exclusion criteria (3 listed)
- Allergy to fish or history of allergic reactions attributable to fish or to a fish oil-like compound.
- Female who are pregnant or are lactating.
- Intake of omega-3 monoglycerides in the 30 days prior to day 1 of the 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 |
|---|---|---|
| Eicosapentaenoic acid + Docosahexaenoic acidAlso: MaxSimilMonoglyceride Omega-3 fish oils | Dietary supplement | MaxSimil |
| Eicosapentaenoic acidAlso: MAG-EPAMonoglyceride Omega-3 fish oil | Dietary supplement | MAG-EPA |
Primary outcome
Quantification of mitochondrial functions (Oxphos. Leak, RCR)
Time frame: 90 days per subject. About seven months for the whole study.
For both group, mitochondrial functions will be measured at baseline, after 45 days and after 90 days of treatment. Potential improvement will be compared between groups
Measurement of the improvement of the Lactate threshold in athletes
Time frame: 90 days per subject. About seven months for the whole study.
For both group, lactate threshold will be measured at baseline, after 45 days and after 90 days of treatment. Potential improvement will be compared between groups
3 secondary outcomes
Quantification of inflammation markers (Cytokines)
Time frame: 90 days per subject. About seven months for the whole study.
measurement of the Omega-3 index
Time frame: 90 days per subject. About seven months for the whole study.
Recording and monitoring of life habits
Time frame: 90 days per subject. About seven months for the whole study.
Results and safety
The study was stopped early (reason given: Several impacts of COVID-19 on recruitment and organization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Eicosapentaenoic acid + Docosahexaenoic acid and Eicosapentaenoic acid in people with Healthy Athletes, run by Samuel Fortin at 1 site in Canada.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Apr 2022. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Several impacts of COVID-19 on recruitment and organization). Results are not available in the source record.
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?
Quantification of mitochondrial functions (Oxphos. Leak, RCR) (time frame: 90 days per subject. About seven months for the whole study.). 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 15 Apr 2022.