Clinical trial NCT05581849: Prolonged Nightly Fasting in Fibromyalgia
Official title: Prolonged Nightly Fasting in Individuals With Fibromyalgia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibromyalgia
Keywords: intermittent fasting
chronic pain
quantitative sensory testing
sleep
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 most up-to-date 2016 American College of Rheumatology (ACR) Criteria for Fibromyalgia
* has a smartphone.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility--drop-out rate
timeFrame: At 8 weeks post-treatment
measure: Feasibility--adherence to intervention
timeFrame: At 8 weeks post-treatment
measure: Acceptability of the intervention
timeFrame: At 8 weeks post-treatment
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline and 8 weeks post-treatment
measure: Fibromyalgia symtpoms
timeFrame: Baseline and 8 weeks post-treatment
measure: Cognitive Functioning
timeFrame: Baseline and 8 weeks post-treatment
measure: Pain Severity
timeFrame: Baseline and 8 weeks post-treatment
measure: Central Sensitization Index
timeFrame: Baseline and 8 weeks post-treatment
measure: Pain Interference
timeFrame: Baseline and 8 weeks post-treatment
measure: Inflammatory levels
timeFrame: Baseline and 8 weeks post-treatment
measure: Total Sleep Time (TST)
timeFrame: Baseline and 8 weeks post-treatment
measure: Depressive symptoms
timeFrame: Baseline and 8 weeks post-treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Chung Jung Mun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: