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

NCT03915535 | Terminated Phase 4

• 1 other identifier: PSP-MG01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Athletes

Outcome Measures

Primary Outcomes (2)

• 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

  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

  90 days per subject. About seven months for the whole study.

Secondary Outcomes (3)

• Quantification of inflammation markers (Cytokines)

  90 days per subject. About seven months for the whole study.

• measurement of the Omega-3 index

  90 days per subject. About seven months for the whole study.

• Recording and monitoring of life habits

  90 days per subject. About seven months for the whole study.

Study Arms (2)

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.

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.

Dietary Supplement: Eicosapentaenoic acid

Interventions

Eicosapentaenoic acid + Docosahexaenoic acid DIETARY_SUPPLEMENT

Monoglyceride Omega-3 fish oils

Also known as: MaxSimil

MaxSimil

Eicosapentaenoic acid DIETARY_SUPPLEMENT

Monoglyceride Omega-3 fish oil

Also known as: MAG-EPA

MAG-EPA

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Fortin: lead

Study Sites (1)

Centre Santé 2000

Rimouski, Quebec, G5L 7R4, Canada

Location

MeSH Terms

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids; 1-eicosapentaenoylglycerol

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: September 19, 2019
• Primary Completion: December 18, 2019
• Study Completion: March 28, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)