Prolonged Nightly Fasting in Fibromyalgia

Last updated: April 3, 2025
Sponsor: Arizona State University
Overall Status: Terminated

Phase

N/A

Condition

Fibromyalgia

Treatment

Prolonged Nightly Fasting

Health Education Control

Clinical Study ID

NCT05581849
STUDY00016726
  • Ages 18-65
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age between 18 and 65

  • female

  • able to speak, write, and read English

  • classified as having fibromyalgia based upon criteria established by the mostup-to-date 2016 American College of Rheumatology (ACR) Criteria for Fibromyalgia

  • has a smartphone.

Exclusion

Exclusion Criteria:

  • history of eating disorders assessed by MINI Neuropsychiatric Interview

  • self-report of chronic malignant pain (e.g., cancer, HIV) or systemic inflammatorydisease (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

Study Design

Total Participants: 8
Treatment Group(s): 2
Primary Treatment: Prolonged Nightly Fasting
Phase:
Study Start date:
March 20, 2023
Estimated Completion Date:
April 01, 2025

Study Description

Fibromyalgia is characterized by chronic widespread pain, sleep disturbance, fatigue, negative mood, and cognitive dysfunction. It is estimated about 4 million individuals in the U.S. are affected by fibromyalgia, which results in high disability, lost productivity, and poor quality of life. Various medications have been tested, but findings suggest only small therapeutic effects with high side effects. First line evidence-based psychosocial interventions, such as cognitive behavioral therapy, also yield only small to moderate treatment effects and they require specialized personnel. Thus, there is a dire need to develop a novel approach to manage fibromyalgia symptoms with a high safety profile, are affordable, and are easily implemented by participants without extensive guidance and support from specialized personnel.

Prolonged nightly fasting (PNF) which is a type of time-restricted eating with no or minimal caloric intake for periods of time as few as 12 hours has been shown to promote various health benefits. PNF has also been demonstrated to be highly acceptable and adherable for adults with various clinical condition. Although some dietary patterns have been explored for their impact on pain, the effects of PNF on pain-related outcomes (e.g., pain severity, pain sensitivity), mood, sleep, and inflammation among individuals with fibromyalgia have not been examined. The present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week PNF intervention protocol in 20 adults with fibromyalgia.

Connect with a study center

  • Arizona State University

    Phoenix, Arizona 85004
    United States

    Site Not Available

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