Friedrich-Schiller-University
Jena, Thuringia, 07743, Germany
NCT Number: NCT03558776
KoALA study - assessment of the influence of the background diet on the metabolism and the bioavailability of plant n-3 PUFA from linseed oil.
In particular, the study design focusses on the impact of variations in the background diet as confounding factor (e.g. variations in concurrently intake of linoleic acid (n-6)). Further, the influence of a regular intake of milk fat, in particular from free-grazing ruminants, on n-3 PUFA metabolism will be investigated.
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Notify Me40 year–65 year
All sexes
Interventional
Not applicable
Jena, Thuringia, 07743, Germany
The KoALA study focuses on the impact of variations in the background diet as a confounding factor. The intake of linoleic acid (LA, C18:2 n-6) has been suggested to diminish the metabolism of α-linolenic acid (ALA, C18:3 n-3) to eicosapentaenoic acid (EPA, C20:5 n-3) and docosahexaenoic acid (DHA, 22:6 n-3).
In this context, the proposed study will be conducted to evaluate the influence of the background diet, in particular the impact of the simultaneous intake of LA on the conversion of ALA into their long-chain (LC) metabolites, the incorporation of n-3 LC-PUFA in human tissues and their metabolism into eicosanoids and docosanoids. Further, the influence of a regular intake of milk fat, in particular from free-grazing ruminants, on n-3 PUFA metabolism will be investigated, because short- and middle-chain fatty acids as well as the branched-chain fatty acids in milk fat may influence the conversion of ALA into n-3 LC-PUFA (hypothesis).
Thus, validated nutrition concepts for increasing n-3 LC-PUFA status from plant sources will be developed to ensure an adequate intake of n-3 PUFA according to the guidelines of nutritional societies and as a contribution to the prevention of cardiovascular diseases.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Whether participants meet the inclusion criteria will be evaluated by screening prior the run-in (blood sampling).
Exclusion criteria
linseed oil and defined background diet
Time frame: change from baseline after 4, 8 and 12 weeks
Percentage of EPA and further n-3 PUFA (ALA, DPA, DHA) in plasma and erythrocyte lipids (available from the gas chromatographic analysis)
Time frame: change from baseline after 4, 8 and 12 weeks
Fatty acid distribution in plasma lipids (including SFA, MUFA, PUFA, > 90 fatty acids) available from the gas chromatographic analysis)
Time frame: change from baseline after 4, 8 and 12 weeks
Fatty acid distribution in erythrocyte lipids (including SFA, MUFA, PUFA, > 90 fatty acids) available from the gas chromatographic analysis)
Time frame: change from baseline after 4, 8 and 12 weeks
height, weight, blood pressure, bioelectrical impedance, waist circumstances, heart rate variability
Time frame: change from baseline after 4, 8 and 12 weeks
total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides
Time frame: change from baseline after 4, 8 and 12 weeks
eicosanoids, docosanoids
Time frame: change from baseline after 4, 8 and 12 weeks
Insulin, HbA1c, glucose
Time frame: change from baseline after 4, 8 and 12 weeks
alpha prothrombin time, fibrinogen
Time frame: change from baseline after 4, 8 and 12 weeks
homocysteine; high sensitive c-reactive protein
Time frame: change from baseline after 12 weeks
Unbound free fatty acid profiles in plasma
Time frame: change from baseline after 12 weeks
Cotinin (marker for smoking), Cystatin C (marker for kidney function), NT-pro-BNP (marker for cardiac function, volume regulation), Troponin (TnT or TnI, marker for myocardial necrosis), Galektin 3 (marker for fibrosis), Asymmetric dimethylarginine (ADMA), homoarginine, trimethylamine N-oxide (TMAO)
University of Jena
Other
Influence of the Background Diet on Metabolism of Land-based n-3 PUFA From Linseed Oil - Focus: Conversion of Alpha Linolenic Acid (ALA; KoALA Study)
Acronym: KoALA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.