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Postprandial Response After Intake of Meals With Different Fatty Acid Composition

Primary Purpose

Healthy, Familial Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
SFA muffin
PUFA muffin
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Familial hypercholesterolemia

Healthy

Arm Description

Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline

Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline

Outcomes

Primary Outcome Measures

Change in levels of circulating triglycerides

Secondary Outcome Measures

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.
Changes in circulating levels of inflammatory markers
Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP
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
Changes in lipid classes and lipoprotein size
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.
Check DNA for single nuclear polymorphisms
Changes in PBMC Whole genome transcriptomics

Full Information

First Posted
March 31, 2016
Last Updated
June 29, 2016
Sponsor
University of Oslo
Collaborators
Oslo University Hospital, Mills DA
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1. Study Identification

Unique Protocol Identification Number
NCT02729857
Brief Title
Postprandial Response After Intake of Meals With Different Fatty Acid Composition
Official Title
Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Oslo University Hospital, Mills DA

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Familial Hypercholesterolemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Familial hypercholesterolemia
Arm Type
Experimental
Arm Description
Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
Intervention Type
Dietary Supplement
Intervention Name(s)
SFA muffin
Intervention Description
Muffin rich in saturated fat.
Intervention Type
Dietary Supplement
Intervention Name(s)
PUFA muffin
Intervention Description
Muffin rich in polyunsaturated fat.
Primary Outcome Measure Information:
Title
Change in levels of circulating triglycerides
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Secondary Outcome Measure Information:
Title
Changes in markers of lipid- and glucose metabolism
Description
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.
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in circulating levels of inflammatory markers
Description
Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism
Description
Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level
Time Frame
Measured at baseline and 2, 4 and 6 hours after intake of test meal
Title
Changes in lipid classes and lipoprotein size
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in plasma and urine metabolomics
Description
Changes in metabolites such as glucose, lactate, pyruvate, citrate and amino acids will be measured in plasma and urine.
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.
Title
Check DNA for single nuclear polymorphisms
Time Frame
Measured at baseline and 2,4 and 6 hours after intake of test meal
Title
Changes in PBMC Whole genome transcriptomics
Time Frame
Measured at baseline and 4 and 6 hours after intake of test meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: Untreated Treated with low dose statin (<20 mg atorvastatin, <10-20 mg simvastatin or <5-10 mg rosuvastatin) 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) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Bjørklund Holven, Professor
Organizational Affiliation
Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oslo
City
Oslo
State/Province
Post box 1046, Blindern
ZIP/Postal Code
0317
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Postprandial Response After Intake of Meals With Different Fatty Acid Composition

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