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Trial record 17 of 56 for:    linolenic acid

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

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ClinicalTrials.gov Identifier: NCT03558776
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Christine Dawczynski,PhD, University of Jena

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Endogenous Conversion of Alpha Linolenic Acid Dietary Supplement: linseed oil Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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%).
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : July 22, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Linseed oil plus defined background diet (high linolec acid)
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)
Dietary Supplement: linseed oil
linseed oil and defined background diet

Active Comparator: Linseed oil plus defined background diet (low linolec acid)
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)
Dietary Supplement: linseed oil
linseed oil and defined background diet

Active Comparator: Linseed oil plus defined background diet (high milk)
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)
Dietary Supplement: linseed oil
linseed oil and defined background diet

Placebo Comparator: Linseed oil without defined background diet
Linseed oil (LO) without defined menu plans (D) Western diet, n = 37)
Dietary Supplement: linseed oil
linseed oil and defined background diet




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   50 % male, 50 % female (in the menopause)
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558776


Locations
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Germany
Friedrich-Schiller-University
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena

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Responsible Party: Christine Dawczynski,PhD, Leader of the Junior Research Group Nutritional Concepts, University of Jena
ClinicalTrials.gov Identifier: NCT03558776     History of Changes
Other Study ID Numbers: H6_18
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: publication of the study data and results in national and international journals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christine Dawczynski,PhD, University of Jena:
alpha linolenic acid, linseed oil, eicosapentaenoic acid, docosahexaenoic acid