8 Participants Needed

Prolonged Nightly Fasting for Fibromyalgia

CJ
Overseen ByChung Jung Mun, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking melatonin or any immunosuppressant medications (like steroids) if you are currently using them.

Is prolonged nightly fasting safe for humans?

Research on intermittent fasting, including alternate day fasting, suggests it is generally safe for weight loss and may improve mood and cardiovascular health. However, some concerns about safety and eating disorder symptoms have been raised, so it is important to consult with a healthcare provider before starting such a regimen.12345

How does the treatment Prolonged Nightly Fasting differ from other treatments for fibromyalgia?

Prolonged Nightly Fasting is unique because it involves time-restricted eating, which may enhance mood and relieve pain by increasing brain chemicals like serotonin and endocannabinoids. Unlike conventional treatments, it focuses on dietary behavior and fasting periods to potentially improve chronic pain and mood.56789

What data supports the effectiveness of the treatment Prolonged Nightly Fasting for Fibromyalgia?

Research suggests that fasting, including prolonged nightly fasting, may help improve mood and reduce pain in chronic pain conditions by increasing brain chemicals like serotonin and endocannabinoids. Additionally, intermittent fasting has shown potential benefits in managing chronic pain, which could be relevant for fibromyalgia treatment.5681011

Who Is on the Research Team?

CJ

Chung Jung Mun, Ph.D.

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

This trial is for adult women aged 18-65 with fibromyalgia, as defined by the latest ACR criteria. Participants must be able to use a smartphone and communicate in English. It's not for those who are pregnant, breastfeeding, fasting over 12 hours nightly, working night shifts, have diabetes or eating disorders, plan to move soon, suffer from chronic inflammatory diseases or are using certain medications.

Inclusion Criteria

I have been diagnosed with fibromyalgia according to the 2016 ACR criteria.
I am female.
Has a smartphone.
See 1 more

Exclusion Criteria

History of eating disorders assessed by MINI Neuropsychiatric Interview
I am currently taking melatonin or immunosuppressant drugs like steroids.
I have long-term pain from cancer, HIV, or an inflammatory disease like arthritis or lupus.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week prolonged nightly fasting (PNF) intervention or receive health education control (HEC) content

8 weeks
Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Health Education Control
  • Prolonged Nightly Fasting
Trial Overview The study tests if not eating for an extended time each night (Prolonged Nightly Fasting) for 8 weeks can help reduce pain and improve mood and sleep in people with fibromyalgia. Half of the participants will follow this fasting routine while the other half will receive health education as a control.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged Nightly Fasting (PNF)Experimental Treatment1 Intervention
Group II: Health Education Control (HEC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials
311
Recruited
109,000+

Published Research Related to This Trial

Dietary interventions, such as hypocaloric, raw vegetarian, and low FODMAPs diets, show promise in improving pain and functional outcomes in patients with fibromyalgia, with 5 out of 7 studies reporting positive results.
Despite these promising findings, the overall quality of the studies is low, indicating a need for better-designed research to conclusively determine the effects of dietary interventions on fibromyalgia symptoms.
Dietary interventions in fibromyalgia: a systematic review.Silva, AR., Bernardo, A., Costa, J., et al.[2021]
Intermittent fasting, involving 12 to 16 hours of energy intake restriction, shows promising health benefits that could be particularly useful in managing chronic pain, as suggested by a literature review of various studies.
The review highlights the physiological effects of intermittent fasting and its potential mechanisms for alleviating chronic pain, indicating a need for further research to explore its clinical applications.
Intermittent Fasting: Potential Utility in the Treatment of Chronic Pain across the Clinical Spectrum.Caron, JP., Kreher, MA., Mickle, AM., et al.[2022]
A pilot study involving 48 patients with fibromyalgia found that a multimodal Integrative Medicine (IM) approach, which included fasting therapy, led to significant short-term improvements in fibromyalgia symptoms compared to a conventional rheumatology (CM) approach after 2 weeks.
While the IM approach showed benefits in reducing symptoms like pain and anxiety initially, these effects diminished after 12 weeks, suggesting that while IM may be effective in the short term, further research is needed to evaluate its long-term efficacy.
In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy.Michalsen, A., Li, C., Kaiser, K., et al.[2021]

Citations

Dietary interventions in fibromyalgia: a systematic review. [2021]
Intermittent Fasting: Potential Utility in the Treatment of Chronic Pain across the Clinical Spectrum. [2022]
In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy. [2021]
Prolonged fasting as a method of mood enhancement in chronic pain syndromes: a review of clinical evidence and mechanisms. [2021]
Fasting therapy - an expert panel update of the 2002 consensus guidelines. [2014]
Intermittent fasting and weight loss: Systematic review. [2021]
The role of intermittent fasting and meal timing in weight management and metabolic health. [2020]
Safety of alternate day fasting and effect on disordered eating behaviors. [2018]
Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. [2022]
Psychological and Sleep Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women with Fibromyalgia. [2020]
Dysfunctional eating behavior in fibromyalgia and its association with serum biomarkers of brain plasticity (BDNF and S100B): an exploratory study. [2023]
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