Clinical trial NCT02729857: Postprandial Response After Intake of Meals With Different Fatty Acid Composition
Official title: Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Familial Hypercholesterolemia
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Mills DA
First posted: 2016-04-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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


Eligibility 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)

Primary outcomes:
measure: Change in levels of circulating triglycerides
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary outcomes:
measure: Changes in markers of lipid- and glucose metabolism
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in circulating levels of inflammatory markers
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism
timeFrame: Measured at baseline and 2, 4 and 6 hours after intake of test meal
measure: Changes in lipid classes and lipoprotein size
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in plasma and urine metabolomics
timeFrame: 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.
measure: Check DNA for single nuclear polymorphisms
timeFrame: Measured at baseline and 2,4 and 6 hours after intake of test meal
measure: Changes in PBMC Whole genome transcriptomics
timeFrame: Measured at baseline and 4 and 6 hours after intake of test meal
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
state: Post box 1046, Blindern
Study officials:
affiliation: Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
name: Kirsten Bjørklund Holven, Professor
role: PRINCIPAL_INVESTIGATOR
References: