Effect of Omega-3 Index on Cellular Metabolism and Quality of Life

Study Overview
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Brief Summary
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Determine whether personal optimization of the Omega-3 index improves cellular metabolism and quality of life (according to the SF-36 form).

Official Title
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Effect of Omega-3 Index on Cellular Metabolism and Quality of Life Following the Administration of a Customized Dose of Omega-3 Oil

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: MAG-EPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant aged 19 or over Available for the entire duration of the study and willing to participate on the basis of the information provided in the FIU duly read and signed. Exclusion Criteria: Allergy known to fish Pregnant women who breast-feed or test positive for pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm trial where each participant receives a personalized dose
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAG-EPA<br>MAG-EPA softgel (500mg), daily dose between 1g and 3.5g | Dietary Supplement: MAG-EPA<br>* Based on the result of the participant's Omega-3 index obtained from the blood sampling of visit 1, the daily dose of MAG-EPA will be adjusted to obtain an Omega-3 Index of 8.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 Index | Achievement of an omega-3 index of 8. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular metabolism | To determine whether the achievement of the optimal level of the omega-3 index results in an improvement in the white blood cell energy metabolism | 8 weeks | 
| Quality of life | Determine whether the achievement of the optimal level of the Omega-3 index results in an improvement in quality of life (according to Form SF-36) | 8 weeks | 
| Heart rate | Confirm the link between the optimal omega-3 index and heart rate (bpm) | 8 weeks | 
| Total Cholesterol | Confirm the link between the optimal omega-3 index and total cholesterol (in mmol/L) | 8 weeks | 
| Triglycerides | Confirm the link between the optimal omega-3 index and triglycerides level (in mmol/L) | 8 weeks | 
| HDL-cholesterol | Confirm the link between the optimal omega-3 index and HDL-cholesterol (in mmol/L) | 8 weeks | 
| LDL-cholesterol | Confirm the link between the optimal omega-3 index and LDL-cholesterol (in mmol/L) | 8 weeks | 
| Alanine aminotransferase | Confirm the link between the optimal omega-3 index and alanine aminotransferase (in U/L | 8 weeks | 
| Aspartate aminotransferase | Confirm the link between the optimal omega-3 index and aspartate aminotransferase (in U/L) | 8 weeks | 
| Bilirubin | Confirm the link between the optimal omega-3 index and Bilirubin (in µmol/L) | 8 weeks | 
| Albumin | Confirm the link between the optimal omega-3 index and Albumin (in g/L) | 8 weeks | 
| C-reactive protein | Confirm the link between the optimal omega-3 index and C-reactive protein (in mg/L) | 8 weeks | 
| Apolipoprotein B | Confirm the link between the optimal omega-3 index and Apolipoprotin B (in mmol/L) | 8 weeks | 
| Erythrocyte sedimentation rate | Confirm the link between the optimal omega-3 index and the erythrocyte sedimentation rate (in min) | 8 weeks | 
| Systolic blood pressure | Confirm the link between the optimal omega-3 index and the systolic blood pressure (in mm Hg) | 8 weeks | 
| Diastolic blood pressure | Confirm the link between the optimal omega-3 index and the diastolic blood pressure (in mm Hg) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3 Index, Cellular metabolism, EPA Monoglyceride, Quality of life