Dietary strategies to help fibromyalgia in overweight or obese women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-arm study compares three dietary approaches in female adults with fibromyalgia and overweight or obesity. Participants will be assigned to a very low-calorie ketogenic diet, a Mediterranean diet, or a Mediterranean diet enriched with a probiotic that can produce GABA. The study will measure fibromyalgia severity, sleep, anxiety, and depression using validated questionnaires, along with changes in body composition, metabolic profile, and gut microbiota. Additional analyses include neurosteroid markers and, in a subset, brain GABA and glutamate by MR spectroscopy. The trial is conducted at Genoa-based rheumatology and internal medicine centers and is sponsored by the University of Genoa.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult female patients with fibromyalgia, aged ≤ 65 years, who are overweight or obese (BMI 24.9 \< ≤34.9 kg/m2);
* Patients able to independently provide their written informed consent to participate in the study;
* Patients motivated to participate in the project and able to independently manage the dietary plans provided for in the study.

Exclusion Criteria:

* Lack of signature on informed consent form
* Age \< 18 and \> 65 years
* Male gender
* Patients with food allergies or celiac disease, type 1 diabetes mellitus and autoimmune forms of diabetes mellitus or with severe pancreatic beta cell dysfunction, undergoing treatment with SGLT2 inhibitors, with recent cardiovascular or cerebrovascular events, liver failure, moderate or severe renal failure, respiratory failure, episodes of gout, kidney stones, electrolyte disturbances, NYHA class III-IV heart failure, unstable angina, cardiac arrhythmias or myocardial infarction within the last 12 months, severe depression or any other psychiatric illness, drug, narcotic or alcohol abuse, frail patients, pregnancy and/or breastfeeding, patients about to undergo surgery or invasive procedures, rare diseases (porphyria, carnitine deficiency, carnitine palmitoyltransferase, carnitine acylcarnitine translocase and pyruvate carboxylase, mitochondrial beta oxidation disorders), treatment with diuretics.
* Use of prebiotics and/or probiotics not included in the study, or other dietary supplements in the month prior to enrollment
* Antibiotic treatment less than 3 months prior to enrollment
* Infections at the time of enrollment or any chronic gastrointestinal disorder (e.g., Crohn's disease)
* Significant eating problems (e.g., dysphagia).

Where it's running

• Department of Internal and Medical Specialities (university of Genoa)
  Genova, Genova, Italy Recruiting

Study contacts

• Study coordinator: Alberto Sulli, Professor
• Email: alberto.sulli@unige.it
• Phone: 010-35338710

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.