Cardiometabolic Health and Inflammatory Resolution

Recruiting

• Conditions: Volunteers

• Registration Number: NCT04256330
• Lead Sponsor: Göteborg University

Brief Summary

The aim of this study is to determine how inflammatory resolution impacts cardiometabolic health and disease in subjects that are either lean (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (\>30.0 kg/m2).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-23
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-12-31
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Informed signed consent has been obtained from the volunteer.
• The volunteer has a BMI greater than 18.5 kg/m2

Exclusion Criteria

• The study staff contacting a potential participant perceives that the individual has difficulty understanding the information.
• An MD determines that the individual is on too many medications to participate
• The individual takes a medication that is approved by the MD, but he/she is not willing or not able to wait with any potential morning medication until after their fasted blood-draw.
• The individual is younger than 18 years (relevant for the FAINT-1 and FAINT-2 cohorts)
• The individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication.
• The individual has some form of chronic inflammation.
• The individual regularly uses medication that affects inflammatory resolution (e.g., low-dose aspirin).
• The individual uses immunosuppressive drugs (eg, methotrexate).
• The individual regularly consumes fish oils (omega 3).
• The individual has significant gastrointestinal problems.
• The individual smokes or uses chewing tobacco.
• The individual has been drinking alcohol two days before the study visit.
• The individual has tattoos or body piercings on the forearms and / or the stomach that can affect the examination.
• The individual does not follow instructions given in the research study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory status	2027	The inflammatory status, defined as CRP levels and ability to respond to pro-resolving therapeutics, will be studied in all 6 groups

Trial Locations

Locations (1)

Gothenburg university; 🇸🇪 Gothenburg, Vastra Gotaland, Sweden