MedPath

Incorporation of omega-3 fatty acids in healthy humans

Not Applicable
Completed
Conditions
Omega-3 fatty acid supplementation
Not Applicable
Registration Number
ISRCTN96459690
Lead Sponsor
Pronova BioPharma
Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30203029 results

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
80
Inclusion Criteria

1. Healthy males and females
2. Age 18 to 65 years
3. Body mass index 20 to 35 kg/m2
4. Not consuming fish oil or similar supplements
5. Not eating more than one oily fish meal per week
6. Willing to adhere to the study protocol
7. Being able to provide written informed consent
8. Omega-3 index (EPA+DHA in red blood cells_ < 6.5 at screening

Exclusion Criteria

1. Being diabetic (type 1 or type 2)
2. Being vegetarian or vegan and unwilling to consume capsules with a beef gelatine coating
3. Use of prescribed medicine to control inflammation
4. Smokers
5. Chronic gastrointestinal problems (e.g. IBD, IBS, celiac disease, cancer)
6. Allergic to fish
7. Allergic to soybean
8. Participation in another clinical trial (currently or in the 12 weeks prior to study entry)
9. Pregnancy or lactation
10. Blood donations during 3 months prior to or during the study period
11. Omega-3 index (EPA+DHA in red blood cells > 6.5 at screening

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Concentration of EPA and DHA in red blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks
Secondary Outcome Measures
NameTimeMethod
Concentration of EPA and DHA in plasma and white blood cells, measured by gas chromatography at baseline, 1, 4 and 12 weeks
© Copyright 2025. All Rights Reserved by MedPath