HealthyNCT02729857
Postprandial Response After Intake of Meals With Different Fatty Acid Composition
A study testing SFA muffin and PUFA muffin in people with Healthy and Familial Hypercholesterolemia, run by University of Oslo at 1 site in Norway.
Trial summary
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Familial Hypercholesterolemia
- What is being tested?
- SFA muffin and PUFA muffin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
- Conditions
- Healthy, Familial Hypercholesterolemia
- Being tested
- SFA muffin, PUFA muffin
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFA muffinDietary supplement
Muffin rich in saturated fat.
PUFA muffinDietary supplement
Muffin rich in polyunsaturated fat.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: SFA muffin; Dietary 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 Receives: Dietary Supplement: SFA muffin; Dietary Supplement: PUFA muffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of circulating triglycerides
Measured: 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
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.
Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in circulating levels of inflammatory markers
Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP
Measured: 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
Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level
Measured: Measured at baseline and 2, 4 and 6 hours after intake of test meal
Changes in lipid classes and lipoprotein size
Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal
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.
Measured: 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.
Check DNA for single nuclear polymorphisms
Measured: Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in PBMC Whole genome transcriptomics
Measured: Measured at baseline and 4 and 6 hours after intake of test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Mills DA
- Responsible party
- Principal investigator, Kirsten Holven, University of Oslo
- Investigators
- Kirsten Bjørklund Holven, Professor, Principal investigator, Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729857
- Sponsor's protocol ID
- 2015/2392/REK sør-øst B
- Status last verified
- Jun 2016
- First submitted
- 31 Mar 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02729857
- Acronym / sponsor ID
- 2015/2392/REK sør-øst B
- Conditions
- Healthy, Familial Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Mills DA
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familial hypercholesterolemia | Experimental | Dietary Supplement: SFA muffin, Dietary Supplement: PUFA muffinSubjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline |
| Healthy | Active comparator | Dietary Supplement: SFA muffin, Dietary Supplement: PUFA muffinSubjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFA muffinMuffin rich in saturated fat. | Dietary supplement | Familial hypercholesterolemia, Healthy |
| PUFA muffinMuffin rich in polyunsaturated fat. | Dietary supplement | Familial hypercholesterolemia, Healthy |
Primary outcome
Change in levels of circulating triglycerides
Time frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
7 secondary outcomes
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 circulating levels of inflammatory markers
Time frame: 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
Time frame: Measured at baseline and 2, 4 and 6 hours after intake of test meal
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Bjørklund Holven, Professor principal investigator
Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFA muffin and PUFA muffin in people with Healthy and Familial Hypercholesterolemia, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of circulating triglycerides (time frame: Measured at baseline and 2,4 and 6 hours after intake of test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.