Clinical trial NCT03915535: Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold
Official title: Impact of Two Formulations of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold in Athletes. A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy Athletes
Lead sponsor: SCF Pharma
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Quantification of mitochondrial functions (Oxphos. Leak, RCR)
timeFrame: 90 days per subject. About seven months for the whole study.
measure: Measurement of the improvement of the Lactate threshold in athletes
timeFrame: 90 days per subject. About seven months for the whole study.
Secondary outcomes:
measure: Quantification of inflammation markers (Cytokines)
timeFrame: 90 days per subject. About seven months for the whole study.
measure: measurement of the Omega-3 index
timeFrame: 90 days per subject. About seven months for the whole study.
measure: Recording and monitoring of life habits
timeFrame: 90 days per subject. About seven months for the whole study.
Other outcomes:
Locations:
city: Rimouski
country: Canada
facility: Centre Santé 2000
state: Quebec
Study officials:
References: