Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold
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|ClinicalTrials.gov Identifier: NCT03915535|
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Athletes||Dietary Supplement: Eicosapentaenoic acid + Docosahexaenoic acid Dietary Supplement: Eicosapentaenoic acid||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|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|
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
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
- 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
- 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.
- 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.
- 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.
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
|Centre Santé 2000|
|Rimouski, Quebec, Canada, G5L 7R4|