FibromyalgiaNCT05581849
Prolonged Nightly Fasting in Fibromyalgia
A study testing Prolonged Nightly Fasting in people with Fibromyalgia, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Prolonged Nightly Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- currently trying to lose weight
- currently routinely fasting more than 12 hours a night
- works night shifts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolonged Nightly Fasting in Individuals With Fibromyalgia: A Pilot Study
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.
Read the 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
- Being tested
- Prolonged Nightly Fasting, Health Education Control
- Keywords
- intermittent fasting, chronic pain, quantitative sensory testing, sleep
- Medical subject headings
- Fibromyalgia, Intermittent Fasting, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Nightly FastingBehavioural
Also called Intermittent 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.
Health Education ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility--drop-out rate
Measured: 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
Measured: 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.
Measured: At 8 weeks post-treatment
Secondary outcomes (9)
Fatigue
Total score of Fatigue Severity Scale (ranges from 9-63; higher score means greater fatigue severity)
Measured: Baseline and 8 weeks post-treatment
Fibromyalgia symtpoms
Total score from Revised Fibromyalgia Impact Questionnaire (FIQR) (ranges from 0-100; higher score means greater fibromyalgia symptom severity)
Measured: Baseline and 8 weeks post-treatment
Cognitive Functioning
Total score from Montreal Cognitive Assessment (MoCA) (ranges from 0-30; higher score means better cognitive functioning)
Measured: Baseline and 8 weeks post-treatment
Pain Severity
Average of 4 items from the Brief Pain Inventory; each rated on a 0 (no pain) to 10 (pain as bad as you can imagine); ratings are made of pain right now, typical pain, worst pain, and least pain during the past week.
Measured: Baseline and 8 weeks post-treatment
Central Sensitization Index
Index of thermal temporal summation, mechanical temporal summation, conditioned pain modulation, and aftersensations (this is standardized Z-score)
Measured: Baseline and 8 weeks post-treatment
Pain Interference
Average of 7 items from the Brief Pain Inventory; assessing the extent to which participant experienced that pain interfered with their (1) general activity, (2) mood; (3) walking ability; (4) normal walk; (5) relations with other people, (6) sleep, and (7) enjoyment of life
Measured: Baseline and 8 weeks post-treatment
Inflammatory levels
IL-1β, IL-6, and TNF-α and C-Reactive Protein (CRP) levels
Measured: Baseline and 8 weeks post-treatment
Total Sleep Time (TST)
TST is defined as the total number of minutes asleep between the time a participant goes to bed at night and the time a participant gets out of bed in the morning. TST will be derived from ambulatory EEG sleep monitoring.
Measured: Baseline and 8 weeks post-treatment
Depressive symptoms
T-score from PROMIS Emotional Distress-Depression-Short Form
Measured: Baseline and 8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start20 Mar 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: Study discontinued due to unexpected funding constraints and resource limitations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung Jung Mun, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581849
- Sponsor's protocol ID
- STUDY00016726
- Status last verified
- Apr 2025
- First submitted
- 12 Oct 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Nightly Fasting in Individuals With Fibromyalgia: A Pilot Study
- ClinicalTrials.gov ID
- NCT05581849
- Acronym / sponsor ID
- STUDY00016726
- Conditions
- Fibromyalgia
- Keywords
- intermittent fasting, chronic pain, quantitative sensory testing, sleep
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued due to unexpected funding constraints and resource limitations.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Nightly Fasting (PNF) | Experimental | Behavioral: Prolonged Nightly FastingParticipants will engage in the PNF (14+ hours a night of fasting and no calorie containing food or beverages) for 8 weeks. |
| Health Education Control (HEC) | Active comparator | Behavioral: Health Education ControlParticipants in HEC group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Nightly FastingAlso: Intermittent FastingParticipants 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. | Behavioural | Prolonged Nightly Fasting (PNF) |
| Health Education ControlParticipants 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. | Behavioural | Health Education Control (HEC) |
Primary outcome
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.
9 secondary outcomes
Fatigue
Time frame: Baseline and 8 weeks post-treatment
Fibromyalgia symtpoms
Time frame: Baseline and 8 weeks post-treatment
Cognitive Functioning
Time frame: Baseline and 8 weeks post-treatment
Pain Severity
Time frame: Baseline and 8 weeks post-treatment
Central Sensitization Index
Time frame: Baseline and 8 weeks post-treatment
Pain Interference
Time frame: Baseline and 8 weeks post-treatment
Inflammatory levels
Time frame: Baseline and 8 weeks post-treatment
Total Sleep Time (TST)
Time frame: Baseline and 8 weeks post-treatment
Depressive symptoms
Time frame: Baseline and 8 weeks post-treatment
Results and safety
The study was stopped early (reason given: Study discontinued due to unexpected funding constraints and resource limitations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Jung Mun, Ph.D. principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Nightly Fasting in people with Fibromyalgia, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study discontinued due to unexpected funding constraints and resource limitations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility--drop-out rate (time frame: At 8 weeks post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.