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Postprandial Response After Intake of Meals With Different Fatty Acid Composition

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ClinicalTrials.gov Identifier: NCT02729857
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : June 30, 2016
Sponsor:
Collaborators:
Oslo University Hospital
Mills DA
Information provided by (Responsible Party):
Kirsten Holven, University of Oslo

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
Change in levels of circulating triglycerides [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • Changes in markers of lipid- and glucose metabolism [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
    Changes in levels of total cholesterol, low-density lipoprotein, high-density lipoprotein, apolipoprotein (apo) B, apo A1, apo CIII, apo B48, lipoprotein (a), free fatty acids, total fatty acid composition, LDL-receptor-related protein with 11 ligand-binding repeats (LR11), HbA1c, glucose, insulin and troponin.
  • Changes in circulating levels of inflammatory markers [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
    Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP
  • Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism [ Time Frame: Measured at baseline and 2, 4 and 6 hours after intake of test meal ]
    Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level
  • Changes in lipid classes and lipoprotein size [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
  • Changes in plasma and urine metabolomics [ Time Frame: Measured in plasma at baseline and 2,4 and 6 hours after intake of test meal. Measured in urine at fasting state and during the 6 hour postprandial phase. ]
    Changes in metabolites such as glucose, lactate, pyruvate, citrate and amino acids will be measured in plasma and urine.
  • Check DNA for single nuclear polymorphisms [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
  • Changes in PBMC Whole genome transcriptomics [ Time Frame: Measured at baseline and 4 and 6 hours after intake of test meal ]
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 Postprandial Response After Intake of Meals With Different Fatty Acid Composition
Official Title  ICMJE Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
Brief Summary The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy
  • Familial Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: SFA muffin
    Muffin rich in saturated fat.
  • Dietary Supplement: PUFA muffin
    Muffin rich in polyunsaturated fat.
Study Arms  ICMJE
  • Experimental: Familial hypercholesterolemia
    Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
    Interventions:
    • Dietary Supplement: SFA muffin
    • Dietary Supplement: PUFA muffin
  • Active Comparator: Healthy
    Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
    Interventions:
    • Dietary Supplement: SFA muffin
    • Dietary Supplement: PUFA muffin
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 29, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2016)
40
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 - 30 years of age
  • Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are:

    1. Untreated
    2. Treated with low dose statin (<20 mg atorvastatin, <10-20 mg simvastatin or <5-10 mg rosuvastatin)
    3. Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period)
    4. Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period)
  • BMI 18.5 - 30 kg/m2
  • Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight)

Exclusion Criteria:

  • CRP >10 mg/L
  • TG >4 mmol/L
  • Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism
  • Pregnant or lactating
  • Allergic or intolerant to gluten or egg
  • Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits
  • Using medications affecting lipid metabolism or inflammation, except statins for FH subjects
  • Hormone treatment (except contraception and thyroxin (stabile dose last 3 months))
  • Donating blood 2 months within or during study period
  • Tobacco smoking
  • Large alcohol consumption (>40g daily)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02729857
Other Study ID Numbers  ICMJE 2015/2392/REK sør-øst B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kirsten Holven, University of Oslo
Study Sponsor  ICMJE University of Oslo
Collaborators  ICMJE
  • Oslo University Hospital
  • Mills DA
Investigators  ICMJE
Principal Investigator: Kirsten Bjørklund Holven, Professor Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
PRS Account University of Oslo
Verification Date June 2016

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