MedPath

Influence of omega-3 fatty acids on levels of oxylipins in blood and urine

Not Applicable
Conditions
Investigation of a metabolic pathway in healthy probands
Registration Number
DRKS00006765
Lead Sponsor
eibniz Universität Hannover Institut für Lebensmittelwissenschaft und Humanernährung
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Male
Target Recruitment
32
Inclusion Criteria

•sex: male
•non smoker
•age: 20-40 years
•written confirmation of participants after detailed oral and written explanation about the study contents, and - requirements
•ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the dietary study supplements according to the dosage recommendation)

Exclusion Criteria

•Triglyceride level = 150 mg/dl (= 1,7 mmol/l)
•total cholesterol level = 200 mg/dl (= 5,2 mmol/l)
•BMI: = 20,0 kg/m2 as well as = 27 kg/m2
•relative EPA/DHA content in erythrocyte membranes 4+-2 %
•enzymes: AST (>50 U/L), ALT (>50 U/L), GGT (>60 U/L)
•heavy chronic diseases (manifest chronic heart disease, tumors)
•insulin-dependent persons with diabetes mellitus type I and II
•heavy kidney and liver insuffiency, liver diseases
•chronic diseases of the gastro intestinal tract (especially small intestine, liver, pancreas) as well as surgery in the gut (e.g. gastrectomy, celiac disease, enterocolitis, chronic pancreatitis, cholestase, short bowel syndrome, chronic inflammatory bowel diseases, not: appendix or gallstone operations
•surgery: stomach reduction, gastric banding, stomach balloon
•endocrine and immunologic diseases
•hormonel disorders such as hyperthyroidism or Morbus Cushing
•allergy or incompatibility against fish, fish oil, fish protein
•Regular intake of laxatives
•regular intake of corticosterois and psychotropic drugs
•treatment with lipid lowering drugs (e.g. Fibrates, bile acid exchanger resin, phytosteroles, Ezetimibe, HMG-CoA-reductase inhibitors) in the last three month
•taking any supplements with omega-3 fatty acids, Vitamine E, phytosteroles, polyglucosamines (Chitosan) or other lipid binding ingredients
•fish intake of = 1 times a weak
•diagnosed blood-clotting disorders
•Simultaneous consumption of coagulation-inhibiting drugs (for example Marcumar, ASS)
•alcohol-, drug- and/or medicament dependence
•active participation in other clinical trial within the last 30 days
•subjects who are not in agreement with the study conditions
•refusial or rather reset of the consent from the subject

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
EPA and DHA oxylipins in plasma and plasma after ex vivo inflammatory stimulation
Secondary Outcome Measures
NameTimeMethod
•other oxylipins (besides others LA, AA, DGLA, ALA metabolites) in plasma as well as in plasma after ex vivo inflammatory stimulation and in urine<br>•EPA and DHA oxylipins as well as other oxylipins (i.a. LA, AA, DGLA, ALA metabolites) in urine<br>•pattern of long-chain polyunsaturated fatty acids (i.a. LA, AA, DPA, DGLA, ALA, EPA, DHA) in different blood compartments (total plasma, erythrocyte membranes, free fatty acids, phospholipids, triglycerides, cholesterolesters)<br>•immunologic parameters in plasma and plasma after ex vivo inflammatory stimulation<br>•serum lipides (LDL, HDL, TC, TG)<br>•small blood picture<br>•creatinine in serum<br>•creatinine, uric acid in urine<br>•liver enzymes: AST, ALT, GGT<br>•age, anthropometry (height, weight, BMI), blood pressure<br>•nutrition status, health status<br>•drug intake <br>•compatibility and acceptance of study products<br>
© Copyright 2025. All Rights Reserved by MedPath