Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 6:07 AM
Study NCT ID:
NCT03915535
Status:
TERMINATED
Last Update Posted:
2022-04-15
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold
Sponsor:
Samuel Fortin
Organization:
Study Overview
Official Title:
Impact of Two Formulations of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold in Athletes. A Pilot Study
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Several impacts of COVID-19 on recruitment and organization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: