Postprandial Response After Intake of Meals With Different Fatty Acid Composition

University of Oslo

Status: Completed

Conditions: Healthy; Familial Hypercholesterolemia

Treatments: Dietary Supplement: PUFA muffin; Dietary Supplement: SFA muffin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02729857

2015/2392/REK sør-øst B

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups

Familial hypercholesterolemia

Experimental group

Description:

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

Treatment:

Dietary Supplement: PUFA muffin

Dietary Supplement: SFA muffin

Healthy

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: PUFA muffin

Dietary Supplement: SFA muffin