Examining how men and women differ in resolving inflammation

Investigation of the Distinct Mechanisms Involved in Inflammatory Resolution Between Healthy Men and Women: RESOLVE-SEX

This study is trying to see how men and women handle inflammation differently and if that affects their risk of heart disease.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Queen Mary University of London (other)
• Locations: 1 site (London)
• Trial ID: NCT05597098 on ClinicalTrials.gov

What this trial studies

This study investigates the differences in inflammatory resolution between healthy men and women, focusing on how these differences may relate to coronary artery disease. Using a cantharidin-induced model of acute inflammation, the researchers will analyze inflammatory responses by measuring various biological markers in blister fluid, urine, saliva, and blood. The goal is to understand whether the enhanced ability of women to resolve inflammation contributes to lower rates of coronary artery disease compared to men. This research could provide insights into sex-specific approaches for managing inflammation-related conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy men and women aged 18-45 who are willing to participate.

Not a fit: Patients who are pregnant, breastfeeding, or have a history of serious illnesses or blood-borne infectious diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for coronary artery disease that take into account sex differences in inflammatory responses.

How similar studies have performed: While there have been studies on inflammation and coronary artery disease, this specific investigation into sex differences in inflammatory resolution is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Healthy male and female volunteers
2. Aged 18-45
3. Volunteers who are willing to sign the consent form

Exclusion Criteria:

1. Healthy subjects unwilling to consent
2. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
3. Current breast feeding
4. History of any serious illnesses, including recent infections or trauma
5. Subjects taking systemic medication (other than the oral contraceptive pill)
6. Subjects with recent (2 weeks) or current antibiotic use
7. Subjects with any history of a blood-borne infectious disease such as Hepatitis B or C virus, or HIV

Where this trial is running

London

• The William Harvey Research Institute — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Amrita Ahluwalia, BSc PhD — Queen Mary University of London
• Study coordinator: Amrita Ahluwalia, BSc PhD

Conditions: Inflammation