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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

Brief Summary:
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.

Condition or disease Intervention/treatment Phase
Healthy Familial Hypercholesterolemia Dietary Supplement: SFA muffin Dietary Supplement: PUFA muffin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Dietary Supplement: SFA muffin
Muffin rich in saturated fat.

Dietary Supplement: PUFA muffin
Muffin rich in polyunsaturated fat.

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
Dietary Supplement: SFA muffin
Muffin rich in saturated fat.

Dietary Supplement: PUFA muffin
Muffin rich in polyunsaturated fat.




Primary Outcome Measures :
  1. Change in levels of circulating triglycerides [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. Changes in lipid classes and lipoprotein size [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
  5. 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.

  6. Check DNA for single nuclear polymorphisms [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
  7. Changes in PBMC Whole genome transcriptomics [ Time Frame: Measured at baseline and 4 and 6 hours after intake of test meal ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT02729857


Locations
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Norway
University of Oslo
Oslo, Post box 1046, Blindern, Norway, 0317
Sponsors and Collaborators
University of Oslo
Oslo University Hospital
Mills DA
Investigators
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Principal Investigator: Kirsten Bjørklund Holven, Professor Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
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Responsible Party: Kirsten Holven, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02729857    
Other Study ID Numbers: 2015/2392/REK sør-øst B
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias