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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
Be older than 18 years old
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.

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.

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Who is running the clinical trial?

Arizona State UniversityLead Sponsor
287 Previous Clinical Trials
109,231 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
~9 spots leftby Jun 2025
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