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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159507
• Other study ID #: IO3-01
• Status: Completed
• Phase: Phase 4
• Start date: October 2, 2017
• Est. completion date: March 14, 2019

Study information

• Verified date: October 2018
• Source: SCF Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 14, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• MAG-EPA
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.

Locations

Country	Name	City	State
Canada	SCF Pharma	Rimouski	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
SCF Pharma	Université du Québec à Rimouski

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-3 Index	Achievement of an omega-3 index of 8.	8 weeks
Secondary	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
Secondary	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
Secondary	Heart rate	Confirm the link between the optimal omega-3 index and heart rate (bpm)	8 weeks
Secondary	Total Cholesterol	Confirm the link between the optimal omega-3 index and total cholesterol (in mmol/L)	8 weeks
Secondary	Triglycerides	Confirm the link between the optimal omega-3 index and triglycerides level (in mmol/L)	8 weeks
Secondary	HDL-cholesterol	Confirm the link between the optimal omega-3 index and HDL-cholesterol (in mmol/L)	8 weeks
Secondary	LDL-cholesterol	Confirm the link between the optimal omega-3 index and LDL-cholesterol (in mmol/L)	8 weeks
Secondary	Alanine aminotransferase	Confirm the link between the optimal omega-3 index and alanine aminotransferase (in U/L	8 weeks
Secondary	Aspartate aminotransferase	Confirm the link between the optimal omega-3 index and aspartate aminotransferase (in U/L)	8 weeks
Secondary	Bilirubin	Confirm the link between the optimal omega-3 index and Bilirubin (in µmol/L)	8 weeks
Secondary	Albumin	Confirm the link between the optimal omega-3 index and Albumin (in g/L)	8 weeks
Secondary	C-reactive protein	Confirm the link between the optimal omega-3 index and C-reactive protein (in mg/L)	8 weeks
Secondary	Apolipoprotein B	Confirm the link between the optimal omega-3 index and Apolipoprotin B (in mmol/L)	8 weeks
Secondary	Erythrocyte sedimentation rate	Confirm the link between the optimal omega-3 index and the erythrocyte sedimentation rate (in min)	8 weeks
Secondary	Systolic blood pressure	Confirm the link between the optimal omega-3 index and the systolic blood pressure (in mm Hg)	8 weeks
Secondary	Diastolic blood pressure	Confirm the link between the optimal omega-3 index and the diastolic blood pressure (in mm Hg)	8 weeks