Trial Outcomes & Findings for Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil (NCT NCT02428699)
NCT ID: NCT02428699
Last Updated: 2018-08-28
Results Overview
The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.
COMPLETED
NA
50 participants
Baseline and up to Day 2
2018-08-28
Participant Flow
Participants were recruited at one Centre in United Kingdom.
A total of 93 participants were screened, out of which 50 participants were randomized. 39 participants failed screening and 2 participants withdrew from the study. 2 participants discontinued due to other reasons (reason not specified).
Participant milestones
| Measure |
Scott's Emulsion Followed by Non Emulsified Cod Liver Oil
Sequence 1: Participants were administered 30 milliliters (mL) of Scott's emulsion (10 percent \[%\] Cod Liver Oil, 10% Cod Oil) followed by 300 mL of apple juice in period 1. After a washout period of 2 weeks participants were administered 5.8 mL non emulsified cod liver oil, followed by 300 ml apple juice in period 2.
|
Non Emulsified Cod Liver Oil Followed by Scott's Emulsion
Sequence 2: Firstly, participants were administered 5.8 mL non emulsified cod liver oil, followed by 300 mL of apple juice in Period 1. After a washout period of 2 weeks participants were administered test product i.e. 30 mL of Scott's emulsion (10 % Cod Liver Oil, 10% Cod Oil) followed by 300 mL apple juice in period 2.
|
|---|---|---|
|
Period 1
STARTED
|
25
|
25
|
|
Period 1
COMPLETED
|
25
|
25
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period 1
STARTED
|
25
|
25
|
|
Washout Period 1
COMPLETED
|
24
|
23
|
|
Washout Period 1
NOT COMPLETED
|
1
|
2
|
|
Period 2
STARTED
|
24
|
23
|
|
Period 2
COMPLETED
|
24
|
23
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Scott's Emulsion Followed by Non Emulsified Cod Liver Oil
Sequence 1: Participants were administered 30 milliliters (mL) of Scott's emulsion (10 percent \[%\] Cod Liver Oil, 10% Cod Oil) followed by 300 mL of apple juice in period 1. After a washout period of 2 weeks participants were administered 5.8 mL non emulsified cod liver oil, followed by 300 ml apple juice in period 2.
|
Non Emulsified Cod Liver Oil Followed by Scott's Emulsion
Sequence 2: Firstly, participants were administered 5.8 mL non emulsified cod liver oil, followed by 300 mL of apple juice in Period 1. After a washout period of 2 weeks participants were administered test product i.e. 30 mL of Scott's emulsion (10 % Cod Liver Oil, 10% Cod Oil) followed by 300 mL apple juice in period 2.
|
|---|---|---|
|
Washout Period 1
Screen Failure
|
1
|
2
|
Baseline Characteristics
Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil
Baseline characteristics by cohort
| Measure |
Overall Study
n=50 Participants
Test product : 30 mL Scott's Emulsion containing 10% Cod Liver Oil, 10% Cod Oil. Reference product: 5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|
|
Age, Continuous
|
29.1 Years
STANDARD_DEVIATION 7.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Day 2Population: Per protocol (PP) population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Incremental Area Under the Curve to 24 Hours (h) (iAUC0-24h) of the Sum of Plasma Total and Free n-3 Fatty Acids (Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)
|
13.19 Microgram per mililiter (µg/mL)
Standard Deviation 8.368
|
7.73 Microgram per mililiter (µg/mL)
Standard Deviation 6.532
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
iAUC0-24h of Sum of Total and Free DHA
|
5.09 µg/mL
Standard Deviation 6.118
|
2.89 µg/mL
Standard Deviation 4.225
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
iAUC0-24h of Sum of Total and Free EPA
|
8.10 µg/mL
Standard Deviation 2.810
|
4.84 µg/mL
Standard Deviation 2.903
|
SECONDARY outcome
Timeframe: Upto 10 hPopulation: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
iAUC0-10h of Sum of Total and Free DHA
|
7.51 µg/mL
Standard Deviation 6.810
|
3.86 µg/mL
Standard Deviation 4.011
|
SECONDARY outcome
Timeframe: Upto 10 hPopulation: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
iAUC0-10h of Sum of Total and Free EPA
|
7.28 µg/mL
Standard Deviation 2.893
|
3.97 µg/mL
Standard Deviation 2.493
|
SECONDARY outcome
Timeframe: Upto 10 hPopulation: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
iAUC0-10h of Sum of Total and Free DHA and EPA
|
14.79 µg/mL
Standard Deviation 9.336
|
7.83 µg/mL
Standard Deviation 6.133
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA
|
98.37 µg/mL
Standard Deviation 26.595
|
90.48 µg/mL
Standard Deviation 26.252
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Cmax of Sum of Total and Free DHA
|
70.61 µg/mL
Standard Deviation 19.698
|
64.73 µg/mL
Standard Deviation 19.229
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Cmax of Sum of Total and Free EPA
|
28.89 µg/mL
Standard Deviation 8.205
|
26.27 µg/mL
Standard Deviation 8.894
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA
|
5.77 h
Standard Deviation 2.208
|
7.73 h
Standard Deviation 3.480
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Tmax of Sum of Total and Free DHA
|
5.23 h
Standard Deviation 1.790
|
7.56 h
Standard Deviation 4.219
|
SECONDARY outcome
Timeframe: Baseline and up to Day 2Population: PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.
Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined.
Outcome measures
| Measure |
Test Product
n=44 Participants
30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil
|
Reference Product
n=45 Participants
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Tmax of Sum of Total and Free EPA
|
8.36 h
Standard Deviation 4.979
|
8.00 h
Standard Deviation 3.464
|
Adverse Events
Test Product
Reference Product
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product
n=48 participants at risk
30 mL Scott's Emulsion containing 10% cod liver oil, 10% cod oil
|
Reference Product
n=49 participants at risk
5.8 mL of non emulsified free flowing cod liver oil
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.4%
5/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
4.1%
2/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
0.00%
0/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
0.00%
0/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
|
Infections and infestations
Rhinitis
|
2.1%
1/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
0.00%
0/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
0.00%
0/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
|
General disorders
Fatigue
|
2.1%
1/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
0.00%
0/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.1%
1/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
0.00%
0/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/48 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
2.0%
1/49 • approximately 45 days
Safety population (N=50) included all participants who were randomized and administered at least one study treatment during the study (47 participants were treated with both Scott's Emulsion Original and Cod liver oil; 1 participant was treated with Scott's Emulsion only and 2 were treated with Cod liver oil only). Therefore, a total of 48 participants were included in Scotts emulsion (test product) arm and 49 in Cod liver oil (reference product) arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER