Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03735836
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2018-11-02
Brief Title:
Effect of Fish Oil Monoglycerides on the Omega-3 Index
Sponsor:
Samuel Fortin
Organization:
SCF Pharma
Study Overview
Official Title:
Effect of Fish Oil Monoglycerides on the Omega-3 Index Pilot Study IO3-02
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period namely two 2 or three 3 tablets per day MaxSimil is a concentrated fish oil monoglyceride MAG that facilitates absorption of the omega-3 oils by the body Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid MAG-EPA and 130 mg of monoglyceride docosahexaenoic acid MAG-DHA Thirty-two 32 subjects will be enrolled and randomly assigned to one of the two parallel treatment doses Pharmacokinetics will be assessed by measuring the omega-3 index at eight 8 different times during the study A first sample will be taken before the start of treatment and then every four 4 weeks during treatment Then two last measurements of the omega-3 index will be done at four 4 and seven 7 weeks after the end of treatment Apart from the study treatment and collection of samples for the measurement of the omega-3 index the only other interventions will be the measurement of body weight at screening and at the end of the study pregnancy test for women at screening questioning for demographic information and for the follow-up of the subjects health and concomitant medication intake
Detailed Description:
Thirty-two 32 subjects will be enrolled and randomly assigned to one of the two parallel treatment doses The study population will be men and women of 19 years and older with no allergy or history of allergy to fish Participants must not have taken omega-3 supplements in the last 60 days prior to study enrollment Pregnant or lactating women will be excluded from the study
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period of treatment namely two 2 or three 3 tablets per day MaxSimil is a concentrated monoglyceride MAG form of omega-3 fish oil that is better absorbed by the body compared to regular fish oil Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid MAG-EPA and 130 mg of monoglyceride docosahexaenoic acid MAG-DHA
Pharmacokinetics will be assessed by measuring the omega-3 index at eight 8 different times during the study A first blood sample will be taken before the start of treatment and then at week four 4 eight 8 twelve 12 sixteen 16 and twenty 20 Then two last measurements of the omega-3 index will be done at four 4 and seven 7 weeks after the end of treatment The samples will all be taken by capillary puncture during visits at the clinic A total of nine 9 visits may be done including the recruitmentscreeningenrollment visit Visit 1 could be done immediately after enrollment for a total of eight 8 visits instead of nine
The screening tasks include pregnancy testing for women measurement of the omega-3 index body weight and height recording of the baseline health status and concomitant treatment Then for visits 2 to 5 study treatment will be dispensed returned and accounted blood sample will be collected for the measurement of the omega-3 index and the health status will be followed for any adverse event outcome
Visits 6 to 8 are post-treatment follow-ups where omega-3 index testing will be done as well as the follow-up of the health status and concomitant medication intake
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period of treatment namely two 2 or three 3 tablets per day MaxSimil is a concentrated monoglyceride MAG form of omega-3 fish oil that is better absorbed by the body compared to regular fish oil Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid MAG-EPA and 130 mg of monoglyceride docosahexaenoic acid MAG-DHA
Pharmacokinetics will be assessed by measuring the omega-3 index at eight 8 different times during the study A first blood sample will be taken before the start of treatment and then at week four 4 eight 8 twelve 12 sixteen 16 and twenty 20 Then two last measurements of the omega-3 index will be done at four 4 and seven 7 weeks after the end of treatment The samples will all be taken by capillary puncture during visits at the clinic A total of nine 9 visits may be done including the recruitmentscreeningenrollment visit Visit 1 could be done immediately after enrollment for a total of eight 8 visits instead of nine
The screening tasks include pregnancy testing for women measurement of the omega-3 index body weight and height recording of the baseline health status and concomitant treatment Then for visits 2 to 5 study treatment will be dispensed returned and accounted blood sample will be collected for the measurement of the omega-3 index and the health status will be followed for any adverse event outcome
Visits 6 to 8 are post-treatment follow-ups where omega-3 index testing will be done as well as the follow-up of the health status and concomitant medication intake
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None