Prolonged Nightly Fasting in Fibromyalgia

Stopped early · Not applicable

Conditions studied: Fibromyalgia

In brief

The present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week prolonged nightly fasting (PNF) intervention protocol in 20 adults with fibromyalgia. Aim 1: Evaluate feasibility and acceptability of the PNF intervention among participants with fibromyalgia. Aim 2: Evaluate preliminary efficacy of PNF on pain severity and sensitivity, mood, sleep and inflammation.

Key facts

Study ID

NCT05581849

Run by

Arizona State University

People needed

8

Starts

2023-03-20

Expected to finish

2025-04-01

Last updated by the study team

2025-04-06

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• age between 18 and 65
• female
• able to speak, write, and read English
• classified as having fibromyalgia based upon criteria established by the most up-to-date 2016 American College of Rheumatology (ACR) Criteria for Fibromyalgia
• has a smartphone.

You may not qualify if…

• history of eating disorders assessed by MINI Neuropsychiatric Interview
• self-report of chronic malignant pain (e.g., cancer, HIV) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus)
• current use of melatonin or an immunosuppressant medication (e.g., steroids)
• currently pregnant, trying to get pregnant, or breastfeeding
• plans to relocate within the next 6 months
• has diabetes mellitus
• currently trying to lose weight
• currently routinely fasting more than 12 hours a night
• works night shifts

Where it is running

• Arizona State University — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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