- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06640036
FILIP: Fat Intake, Inflammation and LIPids (FILIP)
Low-grade inflammation is involved in the pathogenesis of type 2 diabetes and cardiovascular disease. Increasing evidence suggests that dietary intake may be involved in the inflammatory process. How nutritional composition of the diet affects the inflammatory response is however not well understood.
The aim of this project is to study if intake of three different fat sources induce different effects on inflammation markers, blood lipids, blood glucose and the microbiota.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gothenburg, Sweden, 40530
- University of Gothenburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-60
- Willing to eat the study diet
Exclusion Criteria:
- malabsorption-related condition
- contraindications to consume a high fat diet
- intolerance to any foods used in the study (e.g. cow's milk, egg, gluten)
- established cardiovascular disease, diabetes or cancer
- current use of medication known to affect lipid metabolism (e.g. statins) or inflammation (e.g. NSAID, glucocorticoids).
- hemoglobin <100 g/L
- ongoing pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence 1: Rapeseed oil, butter, coconut oil
Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals
|
During 1 week, 46 % of total energy intake will come from rapeseed oil, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from butter, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from coconut oil, using pre-prepared and blinded meals.
|
|
Experimental: Sequence 2: Rapeseed oil, coconut oil, butter
Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals
|
During 1 week, 46 % of total energy intake will come from rapeseed oil, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from butter, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from coconut oil, using pre-prepared and blinded meals.
|
|
Experimental: Sequence 3: Butter, coconut oil , rapeseed oil
Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals
|
During 1 week, 46 % of total energy intake will come from rapeseed oil, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from butter, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from coconut oil, using pre-prepared and blinded meals.
|
|
Experimental: Sequence 4: Butter, rapeseed oil, coconut oil
Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals
|
During 1 week, 46 % of total energy intake will come from rapeseed oil, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from butter, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from coconut oil, using pre-prepared and blinded meals.
|
|
Experimental: Sequence 5: Coconut oil, rapeseed oil, butter
Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals
|
During 1 week, 46 % of total energy intake will come from rapeseed oil, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from butter, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from coconut oil, using pre-prepared and blinded meals.
|
|
Experimental: Sequence 6: Coconut oil, butter, rapeseed oil
Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals
|
During 1 week, 46 % of total energy intake will come from rapeseed oil, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from butter, using pre-prepared and blinded meals.
During 1 week, 46 % of total energy intake will come from coconut oil, using pre-prepared and blinded meals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total cholesterol
Time Frame: Baseline and 1 week
|
Baseline and 1 week
|
|
|
hs-CRP
Time Frame: Baseline and 1 week
|
High sensitivity C-reactive Protein
|
Baseline and 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammation markers
Time Frame: Baseline and 1 week
|
Eg. GlycA, IL6, TNF-a
|
Baseline and 1 week
|
|
Blood lipid propfile
Time Frame: Baseline and 1 week
|
Blood lipids and their subfractions, lipoproteins, apolipoproteins
|
Baseline and 1 week
|
|
Glucose
Time Frame: Continuous during 1 week
|
Glucose, measured by continuous blood glucose monitoring
|
Continuous during 1 week
|
|
Microbiota
Time Frame: Baseline and 1 week
|
Change in gut microbial composition and diversity (alpha- and beta).
|
Baseline and 1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-03117-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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