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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linseed oil plus defined background diet (high linolec acid) | Active Comparator | Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: A) 7 ± 2 En% linoleic acid (n = 37) |
|
| Linseed oil plus defined background diet (low linolec acid) | Active Comparator | Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: B) < 2.5 En% linoleic acid (n = 37) |
|
| Linseed oil plus defined background diet (high milk) | Active Comparator | Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: C) 15 ± 2 En% milk fat (n = 37) |
|
| Linseed oil without defined background diet | Placebo Comparator | Linseed oil (LO) without defined menu plans (D) Western diet, n = 37) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linseed oil | Dietary Supplement | linseed oil and defined background diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of EPA and further n-3 PUFA in plasma and erythrocyte lipids | Percentage of EPA and further n-3 PUFA (ALA, DPA, DHA) in plasma and erythrocyte lipids (available from the gas chromatographic analysis) | change from baseline after 4, 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatty acid distribution in plasma lipids | Fatty acid distribution in plasma lipids (including SFA, MUFA, PUFA, > 90 fatty acids) available from the gas chromatographic analysis) | change from baseline after 4, 8 and 12 weeks |
| Fatty acid distribution in erythrocyte lipids |
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Inclusion Criteria:
Whether participants meet the inclusion criteria will be evaluated by screening prior the run-in (blood sampling).
Exclusion Criteria:
50 % male, 50 % female (in the menopause)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich-Schiller-University | Jena | Thuringia | 07743 | Germany |
publication of the study data and results in national and international journals
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| ID | Term |
|---|---|
| D008043 | Linseed Oil |
| ID | Term |
|---|---|
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 |
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Blood samples will be taken at the beginning and regularly every four weeks during the 12-weeks intervention period. For all groups, the consumption of additional n-3 PUFA sources is not permitted during the entire intervention period. The study intervention will consist of a daily dose of linseed oil (LO, 10 En%) and prepared daily menu plans determining the background diet, except for the control group D. The fat composition of the developed daily menu plans (fat content 20 En%) will differ between the groups A to C. For groups A to C, the daily menu plans will ensure an adequate intake of energy and nutrients according to the guidelines of the German Society of Nutrition. Group D serves as control because in this group the background diet is not fixed by menu plans. Participants of group D must follow their normal dietary habits, i.e. a typical Western diet (LA intake is about 15 g/d (5-7 En%) / SFA intake ranges from 10 to 15 En%).
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Fatty acid distribution in erythrocyte lipids (including SFA, MUFA, PUFA, > 90 fatty acids) available from the gas chromatographic analysis) |
| change from baseline after 4, 8 and 12 weeks |
| Anthropometric and physiological data | height, weight, blood pressure, bioelectrical impedance, waist circumstances, heart rate variability | change from baseline after 4, 8 and 12 weeks |
| Blood lipids | total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides | change from baseline after 4, 8 and 12 weeks |
| Inflammatory markers | eicosanoids, docosanoids | change from baseline after 4, 8 and 12 weeks |
| Diabetes risk markers | Insulin, HbA1c, glucose | change from baseline after 4, 8 and 12 weeks |
| Clotting markers | alpha prothrombin time, fibrinogen | change from baseline after 4, 8 and 12 weeks |
| Cardiovascular risk factors | homocysteine; high sensitive c-reactive protein | change from baseline after 4, 8 and 12 weeks |
| Unbound free fatty acid profiles in plasma | Unbound free fatty acid profiles in plasma | change from baseline after 12 weeks |
| Futher biomarkers (cardovascular risk factors) | 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) | change from baseline after 12 weeks |
| Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |