Prevention of civilization diseases
Conditions
Interventions
Group 1: 2-week flaxseed supplementation (25 g per day) and diet with ALA / LA ratio of 1: 20 ± 3.
Group 2: 2-week flaxseed supplementation (25 g per day) and diet with ALA / LA ratio of 1: 20 ± 3.
Sponsors
Universität HannoverInstitut 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 |
|---|---|
| Concentration of EPA and DHA in plasma oxylipins at time 0, after one week and after 2 weeks of intervention by blood sampling; 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 |
|---|---|
| Profiles of long-chain polyunsaturated fatty acids (i.a. LA, AA, DPA, DGLA, ALA, EPA, DHA) in various blood compartments (total plasma, erythrocytes membranes, free fatty acids, phospholipids, triglycerides, cholesterol esters); other oxylipins in plasma and urine at timepoint 0, after one week and after 2 weeks of intervention; 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 ; Immunological parameters in plasma (high-sensitivity C-reactive protein (hsCRP), interleukin (IL) -1ß, IL-6, IL-8, tumor necrosis factor (TNF) a, integrin alpha M (CD11), integrin beta-2 (CD18 ), integrin alpha 2 (CD49), chemokines (CC motif) receptor 2 (CCR2), chemokines (CC motif) receptor 5 (CCR5), serum lipids (low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol ( TC), triglycerides (TG)); SNPs of FADS1, FADS2 FADS3, ELOVL2, CYP2J2, EPHX2 and GCKR genes (measurement once at timepoint 0 by blood sampling) | — |
Countries
Germany
Contacts
Public ContactTheresa Greupner
Institut für Lebensmittelwissenschaft und Humanernährung der Universität Hannover
Outcome results
None listed