Endogenous Conversion of Alpha Linolenic Acid Clinical Trial
— KoALAOfficial title:
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)
| NCT number | NCT03558776 |
| Other study ID # | H6_18 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 13, 2018 |
| Est. completion date | December 31, 2018 |
| Verified date | June 2018 |
| Source | University of Jena |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | July 22, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Whether participants meet the inclusion criteria will be evaluated by screening prior the run-in (blood sampling). - Females (in the menopause) and males (50 % each); age: 40 - 65 years; BMI < 30 kg/m2 - Subjects must be able and willing to give written informed consent, and to comply with study procedures - Subjects with moderate elevated LDL cholesterol (> 3 mmol/l), without lipid-lowering medication - Persons who consume a traditional "Western diet" composed of meat, sausage, dairy products, cereals, vegetables, fruits etc. - Precondition: stable eating habits at least one year before enrollment - Subjects must have adequate fluency in the German language to complete the questionnaires and understand the daily menu plans - No antihypertensive medication or stable dose for >3 months prior to start of the study and during the entire study period Exclusion Criteria: - Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, diabe-tes mellitus (type I and II), chronic renal disease, diseases of the parathyroids, diseases necessitat-ing regular phlebotomies other chronic diseases which could affect the results of the present study - Use of medication which could affect the results of the present study including systemic glucocorti-coids, lipid-lowering medication - Hormone replacement therapy - Use of dietary supplements, incl. multivitamins, fish oil capsules, minerals, and trace elements (three months before and during the entire study period) - Weight loss or weight gain (> 3 kg) during the last three months before study begin - Relevant food allergies (e.g. milk, nuts etc.) - Pregnancy or lactation - Transfusion of blood in the last three months before blood sample taking |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Friedrich-Schiller-University | Jena | Thuringia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Jena |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Fatty acid distribution in erythrocyte lipids | 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 | |
| Secondary | Anthropometric and physiological data | height, weight, blood pressure, bioelectrical impedance, waist circumstances, heart rate variability | change from baseline after 4, 8 and 12 weeks | |
| Secondary | Blood lipids | total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides | change from baseline after 4, 8 and 12 weeks | |
| Secondary | Inflammatory markers | eicosanoids, docosanoids | change from baseline after 4, 8 and 12 weeks | |
| Secondary | Diabetes risk markers | Insulin, HbA1c, glucose | change from baseline after 4, 8 and 12 weeks | |
| Secondary | Clotting markers | alpha prothrombin time, fibrinogen | change from baseline after 4, 8 and 12 weeks | |
| Secondary | Cardiovascular risk factors | homocysteine; high sensitive c-reactive protein | change from baseline after 4, 8 and 12 weeks | |
| Secondary | Unbound free fatty acid profiles in plasma | Unbound free fatty acid profiles in plasma | change from baseline after 12 weeks | |
| Secondary | 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 |