Prolonged Nightly Fasting in Fibromyalgia

NCT ID: NCT05581849

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2025-04-01

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prolonged Nightly Fasting

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Health Education Control

Intervention Type: 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.

Interventions

Prolonged Nightly Fasting

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.

Intervention Type: BEHAVIORAL

Health Education Control

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Intermittent Fasting

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chung Jung Mun, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

STUDY00016726

Identifier Type: -

Identifier Source: org_study_id