NCT05674708

Brief Summary

This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response. The main questions it aims to answer are:

  1. 1.What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation?
  2. 2.Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids?
  3. 3.Can postprandial inflammatory or metabolic response be predicted by individual factors at baseline?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

January 3, 2023

Last Update Submit

February 26, 2024

Conditions

Inflammatory ResponseInflammation

Keywords

inflammationdietfat

Outcome Measures

Primary Outcomes (1)

  • Inflammation markers

    Cytokines, chemokines, endothelial factors

    0, 2, 4 and 6 hours

Secondary Outcomes (5)

  • Lipoproteins

    0, 2, 4 and 6 hours

  • Lipidomics

    0, 2, 4 and 6 hours

  • Blood glucose

    0, 0.5, 1, 2, 4, 6 hours

  • Blood pressure

    0, 0.5, 1, 2, 4, 6 hours

  • Gene expression

    0 and 4 hours

Study Arms (4)

Butter

ACTIVE COMPARATOR

Butter based meal

Other: Fat intake

Coconut

ACTIVE COMPARATOR

Coconut based meal

Other: Fat intake

Corn oil

ACTIVE COMPARATOR

Corn oil based meal

Other: Fat intake

Flax seed oil

ACTIVE COMPARATOR

Flax seed oil based meal

Other: Fat intake

Interventions

Fat intakeOTHER

Four different sources of dietary fat

ButterCoconutCorn oilFlax seed oil

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>18.5
  • Willingness to eat study meals

You may not qualify if:

  • Diabetes
  • Cardiovascular disease
  • Cancer
  • Dyslipidemia
  • Anemia (Hb \<100)
  • Habitual intake of anti-inflammatory drugs
  • Recent weight change (\>±5%)
  • Pregnancy, lactation
  • Current smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Sweden

Location

MeSH Terms

Conditions

InflammationPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Linnea Bärebring, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 6, 2023

Study Start

February 7, 2023

Primary Completion

January 23, 2024

Study Completion

January 23, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)