Postprandial Response After Intake of Meals With Different Fatty Acid Composition
NCT ID: NCT02729857
Last Updated: 2016-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2016-03-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Familial hypercholesterolemia
Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
SFA muffin
Muffin rich in saturated fat.
PUFA muffin
Muffin rich in polyunsaturated fat.
Healthy
Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
SFA muffin
Muffin rich in saturated fat.
PUFA muffin
Muffin rich in polyunsaturated fat.
Interventions
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SFA muffin
Muffin rich in saturated fat.
PUFA muffin
Muffin rich in polyunsaturated fat.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
30 Years
ALL
Yes
Sponsors
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Oslo University Hospital
OTHER
Mills DA
INDUSTRY
University of Oslo
OTHER
Responsible Party
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Kirsten Holven
Professor
Principal Investigators
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Kirsten Bjørklund Holven, Professor
Role: PRINCIPAL_INVESTIGATOR
Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
Locations
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University of Oslo
Oslo, Post Box 1046, Blindern, Norway
Countries
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Other Identifiers
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2015/2392/REK sør-øst B
Identifier Type: -
Identifier Source: org_study_id