Prolonged Nightly Fasting in Fibromyalgia

NCT05581849 | Terminated

• 1 other identifier: STUDY00016726
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

intermittent fasting; chronic pain; quantitative sensory testing; sleep

Outcome Measures

Primary Outcomes (3)

• Feasibility--drop-out rate

  At 8 weeks post-treatment

• Feasibility--adherence to intervention

  The number of days prolonged nightly fasting was completed divided by the total number of treatment days

  At 8 weeks post-treatment

• Acceptability of the intervention

  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.

  At 8 weeks post-treatment

Secondary Outcomes (9)

• 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

• Central Sensitization Index

  Baseline and 8 weeks post-treatment

Study Arms (2)

Prolonged Nightly Fasting (PNF)

EXPERIMENTAL

Participants will engage in the PNF (14+ hours a night of fasting and no calorie containing food or beverages) for 8 weeks.

Behavioral: Prolonged Nightly Fasting

Health Education Control (HEC)

ACTIVE COMPARATOR

Participants in HEC group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks.

Behavioral: Health Education Control

Interventions

Prolonged Nightly Fasting BEHAVIORAL

Participants will engage in 14+ hours a night of fasting and no calorie containing food or beverages for 8 weeks. Participants will be allotted one "cheat day" per week, during which they will not need to fast (or track their times)- the day may change weekly and will be based on participant preference. Study staff and study participants will engage in a weekly coaching call (via phone; 5-10 minutes). Weekly coaching calls will last through the duration of the 8-week intervention.

Also known as: Intermittent Fasting

Prolonged Nightly Fasting (PNF)

Health Education Control BEHAVIORAL

Participants in this group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks. Participants will be asked to review the video at their convenience, prior to their weekly coaching call (5-10 minutes) with the study staff. Weekly topics will be as follows: Week 1: Sleep hygiene, Week 2: Sun safety, Week 3: Home safety, Week 4: Driving safety, Week 5: Hydration, Week 6: Dental health, Week 7: Working environment, Week 8: Communication.

Health Education Control (HEC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Intermittent Fasting; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Fasting; Feeding Behavior; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chung Jung Mun, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: March 20, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)