A proof of concept study to evaluate the impact of a food supplement on uptake and anti-inflammatory properties of omega-3 fatty acid derived specialized pro-resolution lipid mediators
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00023304
- Lead Sponsor
- Evonik Operations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 19
BMI 25-35,
Omega-3 Index < 6%,
Non-smoker
(1) Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
(2) Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as omega-3 fatty acids, probiotics, anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists, fibers etc.) within 2 weeks prior to study start or during the study
(3) Intake of antibiotics in the last 2 months and laxatives in the last 2 weeks
(4) Significant changes in lifestyle or medication (within last 2 months) or surgical intervention or surgical procedure such as bariatric surgery
(5) Subjects consuming
• food or drinks claimed as ‘probiotic’ more than once weekly
• more than 3 portions of fruits and vegetables (sum) per day
(6) Subjects with stool frequency of = 2 stools per week
(7) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study.
(8) Relevant allergy or known hypersensitivity against compounds of the study preparations
(9) Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
(10) Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
(11) Not willing to abstain on fish consumption or foods / oils high in omga-3 fatty acids, e.g. linseed oil etc.
(12) Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1 and 5.
(13) Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increased levels of omega-3 fatty acids and -metabolites in blood on days 1 and 29 after first intake of the study product, measured per UPLC-MS/MS and GC.
- Secondary Outcome Measures
Name Time Method Increase of omega-3 index (day 1 and day 29 after first ingestion of the study product),<br>Modulation of immune cell differentiation (day 1 and 29),<br>Modulation of inflammatory parameters (day 1, 15, 29),<br>Modulation of the epigenome and the stool microbiota (day 1 and 29).<br><br>