Postprandial Response After Intake of Meals With Different Fatty Acid Composition

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729857
• Other study ID #: 2015/2392/REK sør-øst B
• Status: Completed
• Phase: N/A
• First received: March 31, 2016
• Last updated: June 29, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Healthy
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Dietary Supplement:
• SFA muffin
Muffin rich in saturated fat.
• PUFA muffin
Muffin rich in polyunsaturated fat.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo	Post box 1046, Blindern

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Mills DA, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in levels of circulating triglycerides		Measured at baseline and 2,4 and 6 hours after intake of test meal	No
Secondary	Changes in markers of lipid- and glucose metabolism	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.	Measured at baseline and 2,4 and 6 hours after intake of test meal	No
Secondary	Changes in circulating levels of inflammatory markers	Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP	Measured at baseline and 2,4 and 6 hours after intake of test meal	No
Secondary	Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism	Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level	Measured at baseline and 2, 4 and 6 hours after intake of test meal	No
Secondary	Changes in lipid classes and lipoprotein size		Measured at baseline and 2,4 and 6 hours after intake of test meal	No
Secondary	Changes in plasma and urine metabolomics	Changes in metabolites such as glucose, lactate, pyruvate, citrate and amino acids will be measured in plasma and urine.	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.	No
Secondary	Check DNA for single nuclear polymorphisms		Measured at baseline and 2,4 and 6 hours after intake of test meal	No
Secondary	Changes in PBMC Whole genome transcriptomics		Measured at baseline and 4 and 6 hours after intake of test meal	No