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| Name | Class |
|---|---|
| Hammersmith Medicines Research | OTHER |
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This study is designed to compare the incremental area under the curve from 0 to 24h (iAUC0-24h) of plasma levels of n-3 fatty acids (sum of total and free eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) after ingestion of an emulsified product and a non-emulsified reference control of free flowing cod liver oil at the lowest appropriate dose that is practically acceptable, and as near as possible to the test products' recommended daily dose.
Many dietary lipids are in the form of triglycerides, ethyl esters or phospholipids. During digestion these lipids are subject to hydrolysis, in particular by pancreatic triglyceride lipase. To facilitate the action of the enzyme, lipids are emulsified by the action of bile salts. By increasing the surface area of the fat globules, emulsification increases access to the lipids by pancreatic triglyceride lipase. This study is designed to compare iAUC0-24h of plasma levels of n-3 fatty acids (sum of total and free EPA and DHA) after ingestion of an emulsified product and a non-emulsified reference control of free flowing cod liver oil at the lowest appropriate dose that is practically acceptable, and as near as possible to the test products' recommended daily dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | 30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation |
|
| Control | Active Comparator | 5.8mL of cod liver oil in a free flowing non-emulsified formulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emulsified cod liver oil product | Other | Participants are required to consume the dose (30 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | Baseline and up to Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| iAUC0-24h of Sum of Total and Free DHA | 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. | Baseline and up to Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30106311 | Derived | Conus N, Burgher-Kennedy N, van den Berg F, Kaur Datta G. A randomized trial comparing omega-3 fatty acid plasma levels after ingestion of emulsified and non-emulsified cod liver oil formulations. Curr Med Res Opin. 2019 Apr;35(4):587-593. doi: 10.1080/03007995.2018.1512479. Epub 2018 Sep 28. |
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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).
Participants were recruited at one Centre in United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period 1 |
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| Period 2 |
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Safety population (N=50) was analysis population, defined as all participants who were randomized and administered at least one study treatment during the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | 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. | Posted | Mean | Standard Deviation | Microgram per mililiter (µg/mL) | Baseline and up to Day 2 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product | 30 mL Scott's Emulsion containing 10% cod liver oil, 10% cod oil |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Non-emulsified cod liver oil product | Other | Participants are required to consume the dose (5.8 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min |
|
| iAUC0-24h of Sum of Total and Free EPA | 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. | Baseline and up to Day 2 |
| iAUC0-10h of Sum of Total and Free DHA | 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. | Upto 10 h |
| iAUC0-10h of Sum of Total and Free EPA | 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. | Upto 10 h |
| iAUC0-10h of Sum of Total and Free DHA and EPA | 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. | Upto 10 h |
| Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA | Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | Baseline and up to Day 2 |
| Cmax of Sum of Total and Free DHA | Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | Baseline and up to Day 2 |
| Cmax of Sum of Total and Free EPA | Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | Baseline and up to Day 2 |
| Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined. | Baseline and up to Day 2 |
| Tmax of Sum of Total and Free DHA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined. | Baseline and up to Day 2 |
| Tmax of Sum of Total and Free EPA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined. | Baseline and up to Day 2 |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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30 mL Scott's emulsion containing 10% cod liver Oil, and 10% cod oil |
| OG001 | Reference Product | 5.8 mL of non emulsified free flowing cod liver oil |
|
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| Secondary | iAUC0-24h of Sum of Total and Free DHA | 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. | 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. | Posted | Mean | Standard Deviation | µg/mL | Baseline and up to Day 2 |
|
|
|
| Secondary | iAUC0-24h of Sum of Total and Free EPA | 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. | 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. | Posted | Mean | Standard Deviation | µg/mL | Baseline and up to Day 2 |
|
|
|
| Secondary | iAUC0-10h of Sum of Total and Free DHA | 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. | 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. | Posted | Mean | Standard Deviation | µg/mL | Upto 10 h |
|
|
|
| Secondary | iAUC0-10h of Sum of Total and Free EPA | 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. | 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. | Posted | Mean | Standard Deviation | µg/mL | Upto 10 h |
|
|
|
| Secondary | iAUC0-10h of Sum of Total and Free DHA and EPA | 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. | 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. | Posted | Mean | Standard Deviation | µg/mL | Upto 10 h |
|
|
|
| Secondary | Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA | Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | 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. | Posted | Mean | Standard Deviation | µg/mL | Baseline and up to Day 2 |
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| Secondary | Cmax of Sum of Total and Free DHA | Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | 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. | Posted | Mean | Standard Deviation | µg/mL | Baseline and up to Day 2 |
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|
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| Secondary | Cmax of Sum of Total and Free EPA | Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | 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. | Posted | Mean | Standard Deviation | µg/mL | Baseline and up to Day 2 |
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| Secondary | Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined. | 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. | Posted | Mean | Standard Deviation | h | Baseline and up to Day 2 |
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| Secondary | Tmax of Sum of Total and Free DHA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined. | 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. | Posted | Mean | Standard Deviation | h | Baseline and up to Day 2 |
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| Secondary | Tmax of Sum of Total and Free EPA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined. | 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. | Posted | Mean | Standard Deviation | h | Baseline and up to Day 2 |
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| 0 |
| 48 |
| 0 |
| 48 |
| 9 |
| 48 |
| EG001 | Reference Product | 5.8 mL of non emulsified free flowing cod liver oil | 0 | 49 | 0 | 49 | 3 | 49 |
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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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.