Trial Outcomes & Findings for Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation (NCT NCT01078909)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

125 participants

Primary outcome timeframe

5 months

Results posted on

2023-08-21

Participant Flow

Recruitment and screened occured between September 2011 and March 2012 at the Clinical Research Center at Penn State University.

A computer-generated randomization scheme was developed in advance. The randomization scheme was stratified by sex and age and used a balanced block size of 5 to ensure even distribution among treatment groups. Using this randomization scheme, eligible participants were assigned to blinded treatments at the baseline visit by the study coordinator.

Participant milestones

Participant milestones
Measure	300mg Fish Oil (EPA + DHA) Supplement Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period	600mg Fish Oil (EPA+DHA) Supplement Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period	900mg Fish Oil (EPA + DHA) Supplement Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period	1800mg Fish Oil (EPA + DHA) Supplement Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period	Placebo Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
Overall Study STARTED	25	25	25	25	25
Overall Study COMPLETED	23	21	24	24	23
Overall Study NOT COMPLETED	2	4	1	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300mg Fish Oil (EPA + DHA) Supplement n=23 Participants Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period	600mg Fish Oil (EPA+DHA) Supplement n=21 Participants Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period	900mg Fish Oil (EPA + DHA) Supplement n=24 Participants Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 65 month supplementation period	1800mg Fish Oil (EPA + DHA) Supplement n=24 Participants Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period	Placebo n=23 Participants Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period	Total n=115 Participants Total of all reporting groups
Age, Continuous	25.8 years STANDARD_DEVIATION 7.2 • n=5 Participants	27.1 years STANDARD_DEVIATION 7.3 • n=7 Participants	25.8 years STANDARD_DEVIATION 6.4 • n=5 Participants	26.0 years STANDARD_DEVIATION 5.9 • n=4 Participants	25.7 years STANDARD_DEVIATION 6.7 • n=21 Participants	26.1 years STANDARD_DEVIATION 6.7 • n=8 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	12 Participants n=21 Participants	55 Participants n=8 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	11 Participants n=21 Participants	60 Participants n=8 Participants

PRIMARY outcome

Timeframe: 5 months

Population: One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (\>8%)

Outcome measures

Outcome measures
Measure	300mg Fish Oil (EPA + DHA) Supplement n=23 Participants	600mg Fish Oil (EPA+DHA) Supplement n=21 Participants	900mg Fish Oil (EPA + DHA) Supplement n=24 Participants	1800mg Fish Oil (EPA + DHA) Supplement n=23 Participants	Placebo n=23 Participants
Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment TNF-alpha (pg/mL)	1.4 pg/mL Interval 1.3 to 1.5	1.3 pg/mL Interval 1.1 to 1.5	1.4 pg/mL Interval 1.2 to 1.5	1.5 pg/mL Interval 1.2 to 1.6	1.4 pg/mL Interval 1.1 to 1.6
Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment IL-6 (pg/mL)	0.9 pg/mL Interval 0.7 to 1.1	1 pg/mL Interval 0.8 to 1.2	0.9 pg/mL Interval 0.7 to 1.1	1 pg/mL Interval 0.8 to 1.2	0.9 pg/mL Interval 0.7 to 1.1

PRIMARY outcome

Timeframe: 5 months

Population: One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (\>8%)

Outcome measures

Outcome measures
Measure	300mg Fish Oil (EPA + DHA) Supplement n=23 Participants	600mg Fish Oil (EPA+DHA) Supplement n=21 Participants	900mg Fish Oil (EPA + DHA) Supplement n=24 Participants	1800mg Fish Oil (EPA + DHA) Supplement n=23 Participants	Placebo n=23 Participants
Mean Concentrations of CRP Following 5 Months of Treatment	0.6 mg/dL Interval 0.4 to 1.1	0.5 mg/dL Interval 0.3 to 0.6	0.6 mg/dL Interval 0.4 to 1.0	0.6 mg/dL Interval 0.4 to 0.9	0.5 mg/dL Interval 0.3 to 0.8

SECONDARY outcome

Timeframe: 1, 2, 3 and 5 days post LPS administration

Population: Lipid mediators were unable to be detected; Data were not collected.

0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report.