Prolonged Nightly Fasting in Individuals With Fibromyalgia: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Arizona State University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Feasibility--drop-out rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age between 18 and 65
- •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
Arms & Interventions
Prolonged Nightly Fasting (PNF)
Participants will engage in the PNF (14+ hours a night of fasting and no calorie containing food or beverages) for 8 weeks.
Intervention: Prolonged Nightly Fasting (Behavioral)
Health Education Control (HEC)
Participants in HEC group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks.
Intervention: Health Education Control (Behavioral)
Outcomes
Primary Outcomes
Feasibility--drop-out rate
Time Frame: At 8 weeks post-treatment
Feasibility--adherence to intervention
Time Frame: At 8 weeks post-treatment
The number of days prolonged nightly fasting was completed divided by the total number of treatment days
Acceptability of the intervention
Time Frame: At 8 weeks post-treatment
It will be measured by the Global Satisfaction subscale in an adapted version of the Treatment Satisfaction Questionnaire for Medication. The scores are calculated for each of the subscales, which range from 0 to 100, with higher scores indicating higher patient satisfaction with the intervention.
Secondary Outcomes
- Central Sensitization Index(Baseline and 8 weeks post-treatment)
- Inflammatory levels(Baseline and 8 weeks post-treatment)
- Pain Interference(Baseline and 8 weeks post-treatment)
- Fatigue(Baseline and 8 weeks post-treatment)
- Fibromyalgia symtpoms(Baseline and 8 weeks post-treatment)
- Cognitive Functioning(Baseline and 8 weeks post-treatment)
- Pain Severity(Baseline and 8 weeks post-treatment)
- Total Sleep Time (TST)(Baseline and 8 weeks post-treatment)
- Depressive symptoms(Baseline and 8 weeks post-treatment)