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Prolonged Nightly Fasting for Fibromyalgia

N/A
Recruiting
Led By Chung Jung Mun, Ph.D.
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Classified as having fibromyalgia based upon criteria established by the most up-to-date 2016 American College of Rheumatology (ACR) Criteria for Fibromyalgia
Age between 18 and 65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks post-treatment
Awards & highlights

Study Summary

This trial will test if a diet plan with prolonged fasting can help reduce pain, improve sleep, and improve mood in people with fibromyalgia.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves changing eating patterns rather than medication, side effects may include hunger pangs, irritability or changes in energy levels during fasting periods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with fibromyalgia according to the 2016 ACR criteria.
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I am between 18 and 65 years old.
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I am female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the intervention
Interventional procedure
Feasibility--drop-out rate
Secondary outcome measures
Central Sensitization Index
Cognitive Functioning
Depressive symptoms
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged Nightly Fasting (PNF)Experimental Treatment1 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 Control1 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.

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
282 Previous Clinical Trials
108,954 Total Patients Enrolled
3 Trials studying Fibromyalgia
4,289 Patients Enrolled for Fibromyalgia
Chung Jung Mun, Ph.D.Principal InvestigatorArizona State University
1 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Health Education Control Clinical Trial Eligibility Overview. Trial Name: NCT05581849 — N/A
Fibromyalgia Research Study Groups: Prolonged Nightly Fasting (PNF), Health Education Control (HEC)
Fibromyalgia Clinical Trial 2023: Health Education Control Highlights & Side Effects. Trial Name: NCT05581849 — N/A
Health Education Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT05581849 — N/A
Fibromyalgia Patient Testimony for trial: Trial Name: NCT05581849 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for the experiment?

"Absolutely, clinicaltrials.gov reveals that this medical trial is in search of participants. It was published on March 20th 2023 and modified on the 23rd of March. This study requires enlistment from 20 individuals at 1 site."

Answered by AI

Does this clinical trial permit those below the age of fifty-five to participate?

"This trial is exclusively open to participants between the age ranges of 18 and 65. For those younger than 18, there are 6 different trials available, while seniors aged over 65 have 76 separate clinical studies they may participate in."

Answered by AI

What goals is this research seeking to accomplish?

"The primary objective of this 8 week experiment is to determine the adherence rate of participants towards their assigned intervention. Secondary endpoints include Total Sleep Time (TST), Pain Interference, and Cognitive Functioning as gauged by Montreal Cognitive Assessment scores."

Answered by AI

Am I qualified to partake in this clinical trial?

"This study, which is open to women aged 18-65 who have been clinically diagnosed with fibromyalgia based on 2016 American College of Rheumatology (ACR) Criteria for Fibromyalgia and possess a smartphone, seeks 20 participants."

Answered by AI

What is the upper limit of participants in this clinical trial?

"Affirmative. According to the information made available on clinicaltrials.gov, this research is actively seeking enrolment from participants. This venture was first published on March 20th 2023 and has been modified as recently as March 23rd of the same year. Currently, 1 site requires a total of 20 patients for successful completion of the trial."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Arizona State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

From what I've read about fibromyalgia there is little to no treatment. Sometimes I'm in so much pain it makes me cry. I'd like to help find ways to manage my pain considering they say opiates don't help with fibromyalgia pain.
PatientReceived no prior treatments
~2 spots leftby May 2024