N/A
Completed N=50
Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil
Growth and Development
Source: ClinicalTrials.gov NCT02428699 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: 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; 7.73 Microgram per mililiter (µg/mL) — p=<.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
13.19; 7.73 | <.0001 sig |
| SECONDARY iAUC0-24h of Sum of Total and Free DHA |
5.09; 2.89 | — |
| SECONDARY iAUC0-24h of Sum of Total and Free EPA |
8.10; 4.84 | — |
| SECONDARY iAUC0-10h of Sum of Total and Free DHA |
7.51; 3.86 | — |
| SECONDARY iAUC0-10h of Sum of Total and Free EPA |
7.28; 3.97 | — |
| SECONDARY iAUC0-10h of Sum of Total and Free DHA and EPA |
14.79; 7.83 | — |
| SECONDARY Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA |
98.37; 90.48 | — |
| SECONDARY Cmax of Sum of Total and Free DHA |
70.61; 64.73 | — |
| SECONDARY Cmax of Sum of Total and Free EPA |
28.89; 26.27 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA |
5.77; 7.73 | — |
| SECONDARY Tmax of Sum of Total and Free DHA |
5.23; 7.56 | — |
| SECONDARY Tmax of Sum of Total and Free EPA |
8.36; 8.00 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers aged 18 to 45 years (both inclusive)
- Body mass index (BMI) of 18.5-29.9 kg/m2 inclusive
Exclusion Criteria
- Pregnant or lactating women
- Allergy/intolerance to any study material
- Current or recurrent disease, within 12 months of screening that could affect the metabolism of drug
- Participants who have taken any drug known to induce or inhibit hepatic drug metabolism in 30 days prior to screening
- Positive serum Hepatitis B surface antigen, Hepatitis C antibodies or Human Immunodeficiency Virus (HIV), alcohol or drug abuse
- Smokers taking >5 cigarettes/day; prior or current use of any other nicotine containing product
- Blood donated within 3 months of screening
- Consumed n-3 rich food or beverage or n-3 fortified food or beverage within 72h prior to each study session
Data sourced from ClinicalTrials.gov (NCT02428699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.