FILIP: Fat Intake, Inflammation and LIPids

NCT06640036 | Completed

• 1 other identifier: 2024-03117-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation; Microbiota; Cardiometabolic Risk Factors

Keywords

Blood lipid profile; Low grade inflammation

Outcome Measures

Primary Outcomes (2)

• Total cholesterol

  Baseline and 1 week

• hs-CRP

  High sensitivity C-reactive Protein

  Baseline and 1 week

Secondary Outcomes (4)

• Inflammation markers

  Baseline and 1 week

• Blood lipid propfile

  Baseline and 1 week

• Glucose

  Continuous during 1 week

• Microbiota

  Baseline and 1 week

Study Arms (6)

Sequence 1: Rapeseed oil, butter, coconut oil

EXPERIMENTAL

Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals

Other: Rapeseed oil; Other: Butter; Other: Coconut oil

Sequence 2: Rapeseed oil, coconut oil, butter

EXPERIMENTAL

Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals

Other: Rapeseed oil; Other: Butter; Other: Coconut oil

Sequence 3: Butter, coconut oil , rapeseed oil

EXPERIMENTAL

Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals

Other: Rapeseed oil; Other: Butter; Other: Coconut oil

Sequence 4: Butter, rapeseed oil, coconut oil

EXPERIMENTAL

Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals

Other: Rapeseed oil; Other: Butter; Other: Coconut oil

Sequence 5: Coconut oil, rapeseed oil, butter

EXPERIMENTAL

Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals

Other: Rapeseed oil; Other: Butter; Other: Coconut oil

Sequence 6: Coconut oil, butter, rapeseed oil

EXPERIMENTAL

Diets rich in rapeseed oil, butter or coconut oil given in blinded, preprepared meals

Other: Rapeseed oil; Other: Butter; Other: Coconut oil

Interventions

Rapeseed oil OTHER

During 1 week, 46 % of total energy intake will come from rapeseed oil, using pre-prepared and blinded meals.

Sequence 1: Rapeseed oil, butter, coconut oil; Sequence 2: Rapeseed oil, coconut oil, butter; Sequence 3: Butter, coconut oil , rapeseed oil; Sequence 4: Butter, rapeseed oil, coconut oil; Sequence 5: Coconut oil, rapeseed oil, butter; Sequence 6: Coconut oil, butter, rapeseed oil

Butter OTHER

During 1 week, 46 % of total energy intake will come from butter, using pre-prepared and blinded meals.

Sequence 1: Rapeseed oil, butter, coconut oil; Sequence 2: Rapeseed oil, coconut oil, butter; Sequence 3: Butter, coconut oil , rapeseed oil; Sequence 4: Butter, rapeseed oil, coconut oil; Sequence 5: Coconut oil, rapeseed oil, butter; Sequence 6: Coconut oil, butter, rapeseed oil

Coconut oil OTHER

During 1 week, 46 % of total energy intake will come from coconut oil, using pre-prepared and blinded meals.

Sequence 1: Rapeseed oil, butter, coconut oil; Sequence 2: Rapeseed oil, coconut oil, butter; Sequence 3: Butter, coconut oil , rapeseed oil; Sequence 4: Butter, rapeseed oil, coconut oil; Sequence 5: Coconut oil, rapeseed oil, butter; Sequence 6: Coconut oil, butter, rapeseed oil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• Willing to eat the study diet

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Chalmers University of Technology: collaborator

Study Sites (1)

University of Gothenburg

Gothenburg, 40530, Sweden

Location

MeSH Terms

Conditions

Inflammation

Interventions

Rapeseed Oil; Butter; Coconut Oil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Dietary Fats; Fats; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Meals identical in apperance and taste will be prepared, and blinded.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: April 8, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: February 4, 2026

Record last verified: 2025-04

Locations

SE (1)