Prolonged Nightly Fasting for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Overseen by Chung Jung Mun, Ph.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Arizona State University

Must not be taking: Melatonin, Immunosuppressants

Disqualifiers: Eating disorders, Chronic pain, Inflammatory disease, Diabetes, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{2 3 4 10 11}

Research Team

Chung Jung Mun, Ph.D.

Principal Investigator

Arizona State University

Eligibility Criteria

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• Health Education Control (Behavioral Intervention)
• Prolonged Nightly Fasting (Behavioral Intervention)

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.

Participant Groups

Group I: Prolonged Nightly Fasting (PNF) Experimental Treatment 1 Intervention

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

Group II: Health Education Control (HEC) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Mark McKenna

Arizona State University

Chief Executive Officer

Bachelor’s degree in marketing from Arizona State University, MBA from Azusa Pacific University

Cedric O’Gorman

Arizona State University

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Medically supervised modified fasting (200-500 kcal/day) for 7 to 21 days has shown efficacy in treating rheumatic diseases and chronic pain, with participants often experiencing improved mood and alertness.

Fasting may enhance mood and reduce pain through increased brain levels of serotonin, opioids, and endocannabinoids, along with neuroendocrine activation, suggesting it could be a valuable adjunctive therapy for chronic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged fasting as a method of mood enhancement in chronic pain syndromes: a review of clinical evidence and mechanisms. Michalsen, A.[2021]

Fasting therapy, a well-established treatment in Europe, has shown significant benefits for chronic diseases, particularly rheumatic diseases, and is supported by updated guidelines from an expert panel.

Recent studies suggest that fasting may also help with other conditions like metabolic diseases, pain syndromes, and chronic inflammation, but it must be conducted under the supervision of trained healthcare professionals to ensure safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting therapy - an expert panel update of the 2002 consensus guidelines. Wilhelmi de Toledo, F., Buchinger, A., Burggrabe, H., et al.[2014]

Intermittent fasting (IF) has been shown to result in weight loss ranging from 0.8% to 13.0% of baseline weight across 27 trials, with no serious adverse events reported, indicating it is a safe option for treating obesity.

When compared to traditional calorie-restricted diets, IF produced equivalent weight loss results, and it also improved glycemic control in patients with type 2 diabetes, suggesting its potential effectiveness in managing obesity and related metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting and weight loss: Systematic review. Welton, S., Minty, R., O'Driscoll, T., et al.[2021]

Intermittent fasting, including methods like the 5:2 diet and time-restricted feeding, shows similar weight loss efficacy to standard daily calorie restriction, but many fasting models do not involve strict fasting cycles or complete fasting.

Longer fasting durations, particularly those extending beyond 16 hours, may enhance benefits like fat loss and improved insulin sensitivity, suggesting that the physiological effects of fasting could be more pronounced with sustained fasting periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. Templeman, I., Gonzalez, JT., Thompson, D., et al.[2020]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

A study is being conducted to explore the effects of alternate day fasting (ADF) on healthy non-obese individuals, involving 90 participants, with some having followed ADF for at least 6 months and others starting ADF for 4 weeks.

The research aims to assess various health parameters, including metabolic and cardiovascular effects, using advanced techniques like echocardiography and glucose monitoring, to better understand the physiological impacts of ADF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. Tripolt, NJ., Stekovic, S., Aberer, F., et al.[2022]

In a study of 22 women with fibromyalgia, a Mediterranean diet enriched with tryptophan and magnesium significantly reduced symptoms of anxiety, mood disturbances, eating disorders, and dissatisfaction with body image after 16 weeks.

Despite the positive effects on psychological variables, the enriched diet did not lead to improvements in sleep quality, indicating that while it may help with mental health, it may not address all aspects of fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological and Sleep Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women with Fibromyalgia. Martínez-Rodríguez, A., Rubio-Arias, JÁ., Ramos-Campo, DJ., et al.[2020]

Women with fibromyalgia (FM) exhibited significantly higher rates of emotional eating and concerns about eating, shape, and weight compared to healthy controls, indicating a potential link between FM and disordered eating behaviors.

In the FM group, higher hunger levels were associated with lower serum levels of brain-derived neurotrophic factor (BDNF) and higher levels of S100 calcium-binding protein B (S100B), suggesting that these biomarkers may play a role in the altered hunger and satiety perceptions in FM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysfunctional eating behavior in fibromyalgia and its association with serum biomarkers of brain plasticity (BDNF and S100B): an exploratory study. Elkfury, JL., Antunes, LC., Dal Moro Angoleri, L., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Dietary interventions in fibromyalgia: a systematic review. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Fasting: Potential Utility in the Treatment of Chronic Pain across the Clinical Spectrum. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Prolonged fasting as a method of mood enhancement in chronic pain syndromes: a review of clinical evidence and mechanisms. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Fasting therapy - an expert panel update of the 2002 consensus guidelines. [2014]

6. Canada pubmed.ncbi.nlm.nih.gov

Intermittent fasting and weight loss: Systematic review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Psychological and Sleep Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women with Fibromyalgia. [2020]

11. Brazil pubmed.ncbi.nlm.nih.gov

Dysfunctional eating behavior in fibromyalgia and its association with serum biomarkers of brain plasticity (BDNF and S100B): an exploratory study. [2023]