Postprandial Response After Intake of Meals With Different Fatty Acid Composition

Not Applicable

Completed

• Conditions: Healthy; Familial Hypercholesterolemia
• Interventions: Dietary Supplement: SFA muffin; Dietary Supplement: PUFA muffin

• Registration Number: NCT02729857
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-06
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Familial hypercholesterolemia	SFA muffin	Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
Healthy	PUFA muffin	Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
Healthy	SFA muffin	Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
Familial hypercholesterolemia	PUFA muffin	Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline

Primary Outcome Measures

Name	Time	Method
Change in levels of circulating triglycerides	Measured at baseline and 2,4 and 6 hours after intake of test meal

Secondary Outcome Measures

Name	Time	Method
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.
Changes in PBMC Whole genome transcriptomics	Measured at baseline and 4 and 6 hours after intake of test meal
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
Check DNA for single nuclear polymorphisms	Measured at baseline and 2,4 and 6 hours after intake of test meal
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 lipid classes and lipoprotein size	Measured at baseline and 2,4 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.

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Post box 1046, Blindern, Norway