NCT02729857

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

March 31, 2016

Last Update Submit

June 29, 2016

Conditions

HealthyFamilial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Change in levels of circulating triglycerides

    Measured at baseline and 2,4 and 6 hours after intake of test meal

Secondary Outcomes (7)

  • Changes in markers of lipid- and glucose metabolism

    Measured at baseline and 2,4 and 6 hours after intake of test meal

  • Changes in circulating levels of inflammatory markers

    Measured at baseline and 2,4 and 6 hours after intake of test meal

  • 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 lipid classes and lipoprotein size

    Measured at baseline and 2,4 and 6 hours after intake of test meal

  • 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.

  • +2 more secondary outcomes

Study Arms (2)

Familial hypercholesterolemia

EXPERIMENTAL

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 muffinDietary Supplement: PUFA muffin

Healthy

ACTIVE COMPARATOR

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 muffinDietary Supplement: PUFA muffin

Interventions

SFA muffinDIETARY_SUPPLEMENT

Muffin rich in saturated fat.

Familial hypercholesterolemiaHealthy
PUFA muffinDIETARY_SUPPLEMENT

Muffin rich in polyunsaturated fat.

Familial hypercholesterolemiaHealthy

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Post Box 1046, Blindern, 0317, Norway

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kirsten Bjørklund Holven, Professor

    Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)