Postprandial Response After Intake of Meals With Different Fatty Acid Composition

• ClinicalTrials.gov Identifier: NCT02729857
• Recruitment Status: Completed
• First Posted: April 6, 2016
• Last Update Posted: June 30, 2016
• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital; Mills DA
• Information provided by (Responsible Party): Kirsten Holven, University of Oslo

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy; Familial Hypercholesterolemia	Dietary Supplement: SFA muffin; Dietary Supplement: PUFA muffin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
• Study Start Date: March 2016
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in levels of circulating triglycerides [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]

Secondary Outcome Measures :

1. Changes in markers of lipid- and glucose metabolism [ Time Frame: 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.
2. Changes in circulating levels of inflammatory markers [ Time Frame: 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
3. Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism [ Time Frame: 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
4. Changes in lipid classes and lipoprotein size [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
5. Changes in plasma and urine metabolomics [ Time Frame: 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.
6. Check DNA for single nuclear polymorphisms [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
7. Changes in PBMC Whole genome transcriptomics [ Time Frame: Measured at baseline and 4 and 6 hours after intake of test meal ]

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Norway

University of Oslo

Oslo, Post box 1046, Blindern, Norway, 0317

Sponsors and Collaborators

University of Oslo

Oslo University Hospital

Mills DA

Investigators

• Principal Investigator: Kirsten Bjørklund Holven, Professor; Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo

More Information

• Responsible Party: Kirsten Holven, Professor, University of Oslo
• ClinicalTrials.gov Identifier: NCT02729857
• Other Study ID Numbers: 2015/2392/REK sør-øst B
• First Posted: April 6, 2016
• Last Update Posted: June 30, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Hyperlipoproteinemia Type II; Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Hyperlipoproteinemias