Trial Outcomes & Findings for Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis (NCT NCT00886704)

Results Overview

Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index. Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%. Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit. Values of the HS-Omega-3 Index have been found between 1.5% and 20%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

after eight weeks of intervention

Results posted on

2011-10-07

Participant Flow

190 subjects were screened and gave informed consent, and 50 were enrolled.

The main reason for screen failure (about 95 %) was an omega-3 index \< 5.0%. Additional subjects were excluded because of the lack of any evidence for atherosclerotic disease, hospitalisation or lactose intolerance.

Participant milestones

Participant milestones
Measure	Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)	Convenience Drink Without EPA and DHA
Overall Study STARTED	40	10
Overall Study COMPLETED	40	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Convenience Drink With EPA and DHA (Omega-3 Fatty Acids) n=40 Participants	Convenience Drink Without EPA and DHA n=10 Participants	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants	5 Participants n=4 Participants	20 Participants n=27 Participants
Age, Categorical >=65 years	25 Participants n=93 Participants	5 Participants n=4 Participants	30 Participants n=27 Participants
Age Continuous	65.1 years STANDARD_DEVIATION 6.1 • n=93 Participants	64.5 years STANDARD_DEVIATION 5.9 • n=4 Participants	64.8 years STANDARD_DEVIATION 6.0 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	5 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	5 Participants n=4 Participants	34 Participants n=27 Participants
Region of Enrollment Germany	40 participants n=93 Participants	10 participants n=4 Participants	50 participants n=27 Participants

PRIMARY outcome

Timeframe: after eight weeks of intervention

Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index. Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%. Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit. Values of the HS-Omega-3 Index have been found between 1.5% and 20%.

Outcome measures

Outcome measures
Measure	Convenience Drink With EPA and DHA n=40 Participants Palatability	Convenience Drink Without EPA and DHA n=10 Participants Palatability
Omega-3 Index	4.37 % EPA+DHA in total red cell fatty acids Standard Deviation 0.51	4.71 % EPA+DHA in total red cell fatty acids Standard Deviation 0.73

SECONDARY outcome

Timeframe: at 8 weeks

Population: Per protocol analysis

Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome

Outcome measures

Outcome measures
Measure	Convenience Drink With EPA and DHA n=40 Participants Palatability	Convenience Drink Without EPA and DHA n=10 Participants Palatability
Palatability	8.50 Number on a scale from 0 - 10 Standard Deviation 1.84	8.39 Number on a scale from 0 - 10 Standard Deviation 1.71

Adverse Events

Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Convenience Drink Without EPA and DHA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clemens von Schacky, Head, Preventive Cardiology, University of Munich

Ludwig Maximilians-University Munich

Phone: +498951600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place