Familial Hypercholesterolemia, Healthy
Conditions
Brief summary
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
Interventions
DIETARY_SUPPLEMENTSFA muffin
Muffin rich in saturated fat.
DIETARY_SUPPLEMENTPUFA muffin
Muffin rich in polyunsaturated fat.
Sponsors
Oslo University Hospital
Mills DA
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in levels of circulating triglycerides | Measured at baseline and 2,4 and 6 hours after intake of test meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in circulating levels of inflammatory markers | 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 | 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 | Measured at baseline and 2,4 and 6 hours after intake of test meal | — |
| Changes in markers of lipid- and glucose metabolism | 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. |
| Check DNA for single nuclear polymorphisms | Measured at baseline and 2,4 and 6 hours after intake of test meal | — |
| Changes in PBMC Whole genome transcriptomics | Measured at baseline and 4 and 6 hours after intake of test meal | — |
| Changes in plasma and urine metabolomics | 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. |
Countries
Norway
Outcome results
None listed