prevention of civilization diseases
Conditions
Interventions
Group 1: Single-dose of a pure n-3 DHA-oil in combination with a breakfast. DHA-amount: ~ 2 g
Group 2: Single-dose of a pure n-3 DPA-oil in combination with a breakfast. DHA-amount: ~ 2 g
Group 3: Sin
Sponsors
Institut für Lebensmittelwissenschaft und Humanernährung
Eligibility
Sex/Gender
Male
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Non smoking; omnivores with moderate meat consumption (2x per week) for at least 5 years and low fish consumption (max 1x per week.); written consent of the subjects after detailed oral and written explanation of the course content, requirements and risks; ability and willingness of study participants to follow the instructions of the investigator (compliance with the conditions of the study, taking the test products according to the dosage recommendation, etc.)
Exclusion criteria
Exclusion criteria: severe chronic diseases (manifest cardiovascular diseases, cancer); insulin-dependent individuals with diabetes mellitus type I and II; serious kidney or liver failure, liver disease, chronic diseases of the gastrointestinal tract (especially the small intestine, liver, pancreas) and conditions after surgery on the gastrointestinal tract; e.g. gastrectomy, celiac disease, enterocolitis, chronic pancreatitis, cholestasis, short bowel syndrome, inflammatory bowel disease; not: appendicitis, gallstone surgery; surgery for stomach stapling, gastric band, gastric balloon; known endocrine and immunological disorders; immediate need of a surgical procedure; simultaneous participation in another clinical trial or participation within the past 30 days; not incapacitated subjects; refusal or withdrawal of consent by the subject; patients taking preparations that contain LC n-3 PUFA, phytosterols, polyglucosamine (chitosan), vitamin E or other lipid-lowering ingredients include; triglyceride (TG) levels = 150 mg / dL (= 1.7 mmol / l); total cholesterol (TC) levels = 200 mg / dL (= 5.2 mmol / l); body mass index (BMI): = 20 kg / m2 and = 27 kg / m2; relative AA content in erythrocyte membranes: 15 ± 3%; Relative EPA / DHA content in erythrocyte membranes (Omega-3 Index): 6 ± 2%; liver enzymes: aspartate aminotransferase (AST) (> 50 U / L), alanine aminotransferase (ALT) (> 50 U / L), ?-glutamyl transferase (GGT) (> 60 U / L); hormonal disorders, such as hyperthyroidism and Cushing's syndrome; regular intake of laxatives; regular intake of nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, flurbiprofen, diclofenac; chronic administration of corticosteroids (except inhalative), psychotropic drugs; treatment with lipid lowering agents (e.g., statins, fibrates, "Gallensäureaustauscherharze", ezetimibe) in the last three months; diagnosed blood clotting disorders; taking anticoagulants (anticoagulant drugs), as phenprocoumon and platelet aggregation inhibitors, for example, ASS; alcohol, drugs and / or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EPA and DHA-oxylylins in plasma at baseline and at 7 different time points (2, 4, 6, 8, 24, 48 and 72 hours) after consumption of the test product. EPA-metabolites: Resolvin E1, PGE3, PGD3, 5-HEPE, 8-HEPE, 12-HEPE, 15-HEPE, 8(9) -EpETE, 11(12) -EpETE, 14(15) -EpETE, 17(18) -EpETE, 5,6-diHETE, 5,15-diHETE, 8,9-diHETE, 8,15-diHETE, 11,12-diHETE, 14,15-diHETE, 17,18-diHETE DHA-metabolites: 10(11) -EpDPE, 13(14) -EpDPE, 16(17) -EpDPE, 19(20) -EpDPE, 4,5-DiHDPE, 7,8- DiHDPE, 10,11-DiHDPE, 13,14-diHDPE, 16,17-diHDPE, 19,20-diHDPE | — |
Secondary
| Measure | Time frame |
|---|---|
| Further oxylipins (i.a. LA-, AA-, DGLA-, ALA-metabolites) in plasma at baseline and at 7 different time points (2, 4, 6, 8, 24, 48 and 72 hours) after consumption of the test product. LA-metabolites: THF diol, EKODE, 13-HODE, 9-HODE, 13-oxo-ODE, 9-oxo-ODE, 9,10-DiHOME, 12,13-DiHOME, 9(10)-EpOME, 12(13)-EpOME, 9,12,13-TriHOME, 9,10,13-TriHOME, DGLA metabolites: 15(S)-HETrE, PGE1, PGD1 AA-metabolites: 6-keto-PGF1a, 20-COOH-LTB4, 20-OH-LTB4, TXB2, LXA4, 11,12-,15-TriHETrE, PGF2a, PGE2, PGD2, PGJ2, PGB2, 15-deoxy-PGJ2, 6-trans-LTB4, LTB5, LTB4, LTB3, 5-HETE, 8-HETE, 9-HETE, 11-HETE, 12-HETE, 15-HETE, 20-HETE, 5-oxo-ETE, 15-oxo-ETE, 5(6)-EpETrE, 8(9)-EpETrE, 11(12)-EpETrE, 14(15)-EpETrE, 5,6-DiHETrE, 8,9-DiHETrE, 11,12-DiHETrE, 14,15-DiHETrE ALA metabolites: 9-HOTrE, 13-HOTrE, 9(10)-EpODE, 12(13)-EpODE, 15(16)-EpODE, 9,10-DiHODE, 12,13-DiHODE, 15,16-DiHODE Furthermore, the profiles of long-chain polyunsaturated fatty acids are determined (eg LA, AA, DPA, DGLA, ALA, EPA, DHA) at baseline and at 7 different time points (2, 4, 6, 8, 24, 48 and 72 hours) after consumption of the test product. This should be examined in various blood compartments (total plasma, erythrocyte membranes, free fatty acids, phospholipids, triglycerides, cholesterol esters). The serum lipids (LDL-, HDL-, total cholesterol, triglycerides) are to be determined at the baseline, as well as various SNPs of the fatty acid and oxylipine metabolism (FADS1, FADS2, FADS3, ELOVL2, CYP2J2, EPHX2 and GCKR). A small blood count is also recorded at baseline. The liver enzymes AST, ALT, ?GT are determined 24 hours after consumption of the test product. | — |
Countries
Germany
Contacts
Public ContactTheresa Greupner
Institut für Lebensmittelwissenschaft und Humanernährung der Universität Hannover
Outcome results
None listed