NCT03771612

Inflammation and Daily Life Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

UCLA researchers looking for healthy individuals (age 45-60) to participate in a study investigating whether an anti-inflammatory medication can impact daily life experiences. Everyday for two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily questions during the 2-week period. Participants will also fill out questionnaires and complete a few tasks on the computer: once prior to the 2-week period and once immediately after the 2-week period, both during online study sessions.

Detailed description

Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will first complete a structured telephone interview in order to assess eligibility. The study will begin with filling out questionnaires, as well as an online session to complete some tasks. You will then be randomly assigned to take either an anti-inflammatory medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the following two weeks. You will also be contacted by text message to remind you to take your pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires once daily. After the two weeks are over, you will again complete questionnaires and the online study session with tasks. Finally, two weeks after the second session, you will receive an email to fill out questionnaires online.

Conditions

• Inflammation

Interventions

Type	Name	Description
DRUG	Naproxen	Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
DRUG	Placebos	Half of the participants will be randomly assigned to receive a placebo pill twice daily

Timeline

• Start date: 2022-02-09
• Primary completion: 2023-11-09
• Completion: 2024-06-21
• First posted: 2018-12-11
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study