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Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915535
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Samuel Fortin, SCF Pharma

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Athletes Dietary Supplement: Eicosapentaenoic acid + Docosahexaenoic acid Dietary Supplement: Eicosapentaenoic acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Impact of Two Formulations of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold in Athletes. A Pilot Study
Actual Study Start Date : September 19, 2019
Actual Primary Completion Date : December 18, 2019
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Active Comparator: MaxSimil
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.
Dietary Supplement: Eicosapentaenoic acid + Docosahexaenoic acid
Monoglyceride Omega-3 fish oils
Other Name: MaxSimil

Experimental: MAG-EPA
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.
Dietary Supplement: Eicosapentaenoic acid
Monoglyceride Omega-3 fish oil
Other Name: MAG-EPA




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Quantification of inflammation markers (Cytokines) [ Time Frame: 90 days per subject. About seven months for the whole study. ]
    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.

  2. measurement of the Omega-3 index [ Time Frame: 90 days per subject. About seven months for the whole study. ]
    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.

  3. Recording and monitoring of life habits [ Time Frame: 90 days per subject. About seven months for the whole study. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915535


Locations
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Canada, Quebec
Centre Santé 2000
Rimouski, Quebec, Canada, G5L 7R4
Sponsors and Collaborators
Samuel Fortin
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Responsible Party: Samuel Fortin, Principal Investigator, SCF Pharma
ClinicalTrials.gov Identifier: NCT03915535    
Other Study ID Numbers: PSP-MG01
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No