Trial Outcomes & Findings for SPM Regulation by Fish Oil Supplements in Healthy Volunteers (NCT NCT03347006)
NCT ID: NCT03347006
Last Updated: 2025-05-25
Results Overview
The Primary endpoint of the study will be an increase in peripheral blood SPM levels that will be measured calculated by measuring pre-supplement SPM levels to values measured in plasma after supplementation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
outcomes will be measured 24h post supplementation and compared with baseline values (0h)
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Group 1
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a placebo. Blood will be collected again at 2h, 4h, 6h and 24h after placebo administration, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 1.5g of supplement and blood collected at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 3 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 4.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h after supplementation, 12ml per time interval.
|
Group 2
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a 1.5g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 3 g of supplement and blood collected at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 4.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given placebo and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.
|
Group 3
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a 3 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 4.5 g of supplement and blood collected at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a placebo and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 1.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.
|
Group 4
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a 4.5 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered placebo and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 1.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 3 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.
|
Group 5
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered 4.5 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 3g of marine oils and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 1.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given placebo and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.
|
Group 6
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered 3 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 1.5 g of marine oils and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a placebo and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 4.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.
|
Group 7
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered 1.5 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered placebo and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 4.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 3 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.
|
Group 8
Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered placebo. Blood will be collected again at 2h, 4h, 6h and 24h later, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 4.5 g of marine oils and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 3 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 1.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
2
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This was a cross over study to every participant received each of the treatments
Baseline characteristics by cohort
| Measure |
Study Population
n=22 Participants
Since this is a crossover study all the participants in this study will recieved all the study interventions ie 1.5g, 3g 4.5g of marine oils and placebo. These will be administered in one of 8 sequences which will be determined by assigning the volunteer to one of 8 study groups.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • This was a cross over study to every participant received each of the treatments
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants • This was a cross over study to every participant received each of the treatments
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • This was a cross over study to every participant received each of the treatments
|
|
Age, Continuous
|
26.41 years
STANDARD_DEVIATION 4.01 • n=5 Participants • This was a cross over study
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants • Study was a cross over study so all participants received all treatments
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants • Study was a cross over study so all participants received all treatments
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=5 Participants • Study had a cross over design so all participants received all treatments
|
|
Height
|
1.70 meters
STANDARD_DEVIATION 0.08 • n=5 Participants • Study had a cross over design so all participants received all treatments
|
|
Weight
|
68.54 Kg
STANDARD_DEVIATION 18.16 • n=5 Participants • Study had a cross over design so all participants received all treatments
|
|
body mass index
|
23.45 kg/m2
STANDARD_DEVIATION 4.74 • n=5 Participants • Study had a cross over design so all participants received all treatments
|
|
Systolic Blood Pressure
|
118.2 mmHg
STANDARD_DEVIATION 11.39 • n=5 Participants
|
|
Pulse
|
65.59 bpm
STANDARD_DEVIATION 7.64 • n=5 Participants
|
|
Sodium
|
140.4 mmol/L
STANDARD_DEVIATION 2.59 • n=5 Participants
|
|
Potassium
|
4.434 mmol/L
STANDARD_DEVIATION 0.35 • n=5 Participants
|
|
Chloride ions
|
102 mmol/L
STANDARD_DEVIATION 2.00 • n=5 Participants
|
|
Urea
|
4.818 mmol/L
STANDARD_DEVIATION 1.39 • n=5 Participants
|
|
Creatinine
|
79.09 umol/L)
STANDARD_DEVIATION 12.21 • n=5 Participants
|
|
Protein
|
72.27 g/L
STANDARD_DEVIATION 2.83 • n=5 Participants
|
|
Albumin (g/L)
|
46.59 g/L
STANDARD_DEVIATION 2.52 • n=5 Participants
|
|
Bilirubin
|
9.409 µmol/L
STANDARD_DEVIATION 4.93 • n=5 Participants
|
|
adenosine triphosphate
|
57.5 U/L
STANDARD_DEVIATION 11.35 • n=5 Participants
|
|
Alanine aminotransferase
|
19 U/L
STANDARD_DEVIATION 9.20 • n=5 Participants
|
|
Aspartate Transferase
|
19 U/L
STANDARD_DEVIATION 4.22 • n=5 Participants
|
|
Calcium
|
2.407 mml/L
STANDARD_DEVIATION 0.09 • n=5 Participants
|
|
Phosphate (mmol/L)
|
1.13 mmol/L
STANDARD_DEVIATION 0.14 • n=5 Participants
|
|
Urate
|
284.3 µmol/L
STANDARD_DEVIATION 59.13 • n=5 Participants
|
|
estimated glomerular filtration rate
|
78.38 ml/min/1.73m^2
STANDARD_DEVIATION 7.87 • n=5 Participants
|
|
Cholesterol
|
4.79 mmol/L
STANDARD_DEVIATION 0.79 • n=5 Participants
|
|
Triglycerides
|
0.929 mmol/L
STANDARD_DEVIATION 0.30 • n=5 Participants
|
|
High density lipoprotein
|
1.765 mmol/L
STANDARD_DEVIATION 0.35 • n=5 Participants
|
|
Low density lipoprotein
|
2.602 mmol/L
STANDARD_DEVIATION 0.75 • n=5 Participants
|
|
Cholesterol -HDL ratio
|
2.825 ratio
STANDARD_DEVIATION 0.68 • n=5 Participants
|
|
non-HDL Cholesterol
|
3.025 mmol/L
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
White blood cell count
|
6.195 cells*10^6/L
STANDARD_DEVIATION 1.46 • n=5 Participants
|
|
platelet counts
|
258.6 cells 10^9 /L
STANDARD_DEVIATION 60.69 • n=5 Participants
|
|
Hematocrit
|
0.428 L/L
STANDARD_DEVIATION 0.04 • n=5 Participants
|
|
Red blood cell count
|
4.789 cells 10^12/L
STANDARD_DEVIATION 0.42 • n=5 Participants
|
PRIMARY outcome
Timeframe: outcomes will be measured 24h post supplementation and compared with baseline values (0h)Population: healthy volunteers
The Primary endpoint of the study will be an increase in peripheral blood SPM levels that will be measured calculated by measuring pre-supplement SPM levels to values measured in plasma after supplementation.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo control
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 1
n=22 Participants
1.5 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 2
n=22 Participants
3.0 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 3
n=22 Participants
4.5 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
|---|---|---|---|---|
|
Increase in the Average Peripheral Blood SPM Levels
|
56.49 pg/mL
Standard Deviation 42.54
|
56.91 pg/mL
Standard Deviation 38.50
|
108.8 pg/mL
Standard Deviation 110.3
|
139.7 pg/mL
Standard Deviation 83.44
|
SECONDARY outcome
Timeframe: Outcomes will be measured 24h post supplementation and compared with baseline values (at 0h)Measure ability of peripheral blood neutrophils to uptake S. aureus following pre- and post- supplementation. Looking at relationship between amount of omega-3 fatty acids ingested, the increase in the blood levels of these molecules and white blood cell function.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo control
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 1
n=22 Participants
1.5 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 2
n=22 Participants
3.0 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 3
n=22 Participants
4.5 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
|---|---|---|---|---|
|
Percentage Change in Omega-3 Fatty Acid Levels From Baseline After 24 Hours
|
23.19 percent change from baseline
Standard Error 12.90
|
70.01 percent change from baseline
Standard Error 28.31
|
22.60 percent change from baseline
Standard Error 12.26
|
89.12 percent change from baseline
Standard Error 48.61
|
SECONDARY outcome
Timeframe: outcomes measured 24h post supplementation and compared with baseline values (at 0h)Changes in the expression of protein linked with neutrophil activation, determined by comparing expression levels of this protein in peripheral blood cells pre- and post supplementation.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo control
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 1
n=22 Participants
1.5 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 2
n=22 Participants
3.0 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
Dose 3
n=22 Participants
4.5 g of omega-3 supplement
SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.
* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.
|
|---|---|---|---|---|
|
Changes in the Expression of Peripheral Blood Neutrophil Activation Markers
|
31.97 percent change from baseline values
Standard Error 8.556
|
30.90 percent change from baseline values
Standard Error 8.379
|
6.723 percent change from baseline values
Standard Error 5.859
|
13.93 percent change from baseline values
Standard Error 6.177
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose 3
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
Professor Jesmond Dalli
Queen Mary University of London
Phone: +442078828263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place