Postprandial Response After Intake of Meals With Different Fatty Acid Composition

• Sponsor: University of Oslo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02729857
• Collaborator: Oslo University Hospital (Other), Mills DA (Industry)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 10.3

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 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 [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 [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 [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 [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 [Measured at baseline and 2,4 and 6 hours after intake of test meal]

5. 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.

6. Check DNA for single nuclear polymorphisms [Measured at baseline and 2,4 and 6 hours after intake of test meal]

7. Changes in PBMC Whole genome transcriptomics [Measured at baseline and 4 and 6 hours after intake of test meal]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kirsten Holven, Professor, University of Oslo
• ClinicalTrials.gov Identifier: NCT02729857
• Other Study ID Numbers: 2015/2392/REK sør-øst B
• First Posted: Apr 6, 2016
• Last Update Posted: Jun 30, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia

Study Results

No Results Posted as of Jun 30, 2016