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Completed

NCT Number: NCT03558776

Influence of the Background Diet on Metabolism of Land-based n-3 PUFA

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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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

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).

  • 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

Treatment and study plan

linseed oil

Dietary Supplement

linseed oil and defined background diet

Primary outcomes

  1. Percentage of EPA and further n-3 PUFA in plasma and erythrocyte lipids

    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)

Secondary outcomes

  1. Fatty acid distribution in plasma lipids

    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)

  2. Fatty acid distribution in erythrocyte lipids

    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)

  3. Anthropometric and physiological data

    Time frame: change from baseline after 4, 8 and 12 weeks

    height, weight, blood pressure, bioelectrical impedance, waist circumstances, heart rate variability

  4. Blood lipids

    Time frame: change from baseline after 4, 8 and 12 weeks

    total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides

  5. Inflammatory markers

    Time frame: change from baseline after 4, 8 and 12 weeks

    eicosanoids, docosanoids

  6. Diabetes risk markers

    Time frame: change from baseline after 4, 8 and 12 weeks

    Insulin, HbA1c, glucose

  7. Clotting markers

    Time frame: change from baseline after 4, 8 and 12 weeks

    alpha prothrombin time, fibrinogen

  8. Cardiovascular risk factors

    Time frame: change from baseline after 4, 8 and 12 weeks

    homocysteine; high sensitive c-reactive protein

  9. Unbound free fatty acid profiles in plasma

    Time frame: change from baseline after 12 weeks

    Unbound free fatty acid profiles in plasma

  10. Futher biomarkers (cardovascular risk factors)

    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)

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study 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)

Acronym: KoALA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.