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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE March 13, 2018
Actual Primary Completion Date July 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03558776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • 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)
  • 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)
  • 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
  • Blood lipids [ Time Frame: change from baseline after 4, 8 and 12 weeks ]
    total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides
  • Inflammatory markers [ Time Frame: change from baseline after 4, 8 and 12 weeks ]
    eicosanoids, docosanoids
  • Diabetes risk markers [ Time Frame: change from baseline after 4, 8 and 12 weeks ]
    Insulin, HbA1c, glucose
  • Clotting markers [ Time Frame: change from baseline after 4, 8 and 12 weeks ]
    alpha prothrombin time, fibrinogen
  • Cardiovascular risk factors [ Time Frame: change from baseline after 4, 8 and 12 weeks ]
    homocysteine; high sensitive c-reactive protein
  • Unbound free fatty acid profiles in plasma [ Time Frame: change from baseline after 12 weeks ]
    Unbound free fatty acid profiles in plasma
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of the Background Diet on Metabolism of Land-based n-3 PUFA
Official Title  ICMJE 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)
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Endogenous Conversion of Alpha Linolenic Acid
Intervention  ICMJE Dietary Supplement: linseed oil
linseed oil and defined background diet
Study Arms  ICMJE
  • 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)
    Intervention: Dietary Supplement: linseed oil
  • 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)
    Intervention: Dietary Supplement: linseed oil
  • 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)
    Intervention: Dietary Supplement: linseed oil
  • Placebo Comparator: Linseed oil without defined background diet
    Linseed oil (LO) without defined menu plans (D) Western diet, n = 37)
    Intervention: Dietary Supplement: linseed oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2018)
148
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date July 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: 50 % male, 50 % female (in the menopause)
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558776
Other Study ID Numbers  ICMJE H6_18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: publication of the study data and results in national and international journals
Responsible Party Christine Dawczynski,PhD, University of Jena
Study Sponsor  ICMJE University of Jena
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Jena
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP