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

Tracking Information

• First Submitted Date: March 31, 2016
• First Posted Date: April 6, 2016
• Last Update Posted Date: June 30, 2016
• Study Start Date: March 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 5, 2016): Change in levels of circulating triglycerides [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 5, 2016)

• 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.
• 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
• 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
• Changes in lipid classes and lipoprotein size [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
• 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.
• Check DNA for single nuclear polymorphisms [ Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal ]
• Changes in PBMC Whole genome transcriptomics [ Time Frame: Measured at baseline and 4 and 6 hours after intake of test meal ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Healthy
• Familial Hypercholesterolemia

Intervention

• Dietary Supplement: SFA muffin
  Muffin rich in saturated fat.
• Dietary Supplement: PUFA muffin
  Muffin rich in polyunsaturated fat.

Study Arms

• 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
  Interventions:

  • Dietary Supplement: SFA muffin
  • Dietary Supplement: PUFA muffin
• 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
  Interventions:

  • Dietary Supplement: SFA muffin
  • Dietary Supplement: PUFA muffin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 29, 2016): 31
• Original Estimated Enrollment (submitted: April 5, 2016): 40
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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:

  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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT02729857
• Other Study ID Numbers: 2015/2392/REK sør-øst B
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Kirsten Holven, University of Oslo
• Study Sponsor: University of Oslo

Collaborators

• Oslo University Hospital
• Mills DA

Investigators

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

• PRS Account: University of Oslo
• Verification Date: June 2016