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Completed

NCT Number: NCT02729857

Postprandial Response After Intake of Meals With Different Fatty Acid Composition

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Untreated
  • Treated with low dose statin (<20 mg atorvastatin, <10-20 mg simvastatin or <5-10 mg rosuvastatin)
  • 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)
  • 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)

Treatment and study plan

SFA muffin

Dietary Supplement

Muffin rich in saturated fat.

PUFA muffin

Dietary Supplement

Muffin rich in polyunsaturated fat.

Primary outcomes

  1. Change in levels of circulating triglycerides

    Time frame: Measured at baseline and 2,4 and 6 hours after intake of test meal

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Mills DA
  • Oslo University Hospital

Registry information

Official study title

Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Jun 30, 2016

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.

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