Postprandial Response After Intake of Meals With Different Fatty Acid Composition

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Familial Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: SFA muffin; Dietary supplement: PUFA muffin

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Post box 1046, Blindern
    • Oslo, Post box 1046, Blindern, Norway, 0317
      • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Familial hypercholesterolemia; Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline	Dietary supplement: SFA muffin; Muffin rich in saturated fat.; Dietary supplement: PUFA muffin; Muffin rich in polyunsaturated fat.
Active Comparator: Healthy; Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline	Dietary supplement: SFA muffin; Muffin rich in saturated fat.; Dietary supplement: PUFA muffin; Muffin rich in polyunsaturated fat.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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	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.
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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital; Mills DA
• Investigators: Principal Investigator: Kirsten Bjørklund Holven, Professor, Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypercholesterolemia; Hyperlipoproteinemia Type II
• Other Study ID Numbers: 2015/2392/REK sør-øst B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO