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Diets for overweight women living with fibromyalgia, including a probiotic version

Compares ketogenic and Mediterranean diets in overweight women with fibromyalgia.

Key facts

Who runs it
Universita degli Studi di Genova
Where
Genova, ItalySee the site
Trial code
Registry title
Dietary Strategies for the Treatment of Fibromyalgia in Overweight and Obese Patients
Status
Recruiting
People taking part
90 people, planned
Started
10 Apr 2026
Expected to end
Jun 2028
Type of study
Interventional, 3 groups
Treatments tested
  • Very Low-Calorie Ketogenic Diet
  • Mediterranean diet
  • Mediterranean diet enriched by GABA-producing probiotic
Record updated
30 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women with fibromyalgia who are overweight or have class I obesity and can follow a diet plan on their own.

Age
18 to 65 years
Sex
Women only
Disease stage
Fibromyalgia, with overweight or obesity (BMI above 24.9 and up to 34.9 kg/m2)
Earlier treatment
No prebiotics, probiotics or other dietary supplements in the month before joining. No antibiotics in the 3 months before joining. No treatment with SGLT2 inhibitors or diuretics.

Main reasons for not taking part

  • Men
  • Food allergies, celiac disease, type 1 diabetes, or autoimmune diabetes
  • Recent heart or brain blood vessel problems, heart failure, or heart rhythm problems
  • Moderate or severe kidney failure, liver failure, or respiratory failure
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Age < 18 and > 65 years
  • Lack of signature on informed consent form
  • Male gender
  • Significant eating problems (e.g., dysphagia)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Italy

  • Department of Internal and Medical Specialities (university of Genoa)Genova, ItalyContact: Edoardo Giovanni Giannini, ProfessorTaking people

About the trial

What the trial wants to find out

Spontaneous, non-sponsored, interventional, controlled, randomized, parallel-arm clinical study.

Read full original descriptionShow less

Primary objective To assess the impact of specific dietary approaches (ketogenic diet, Mediterranean diet, or Mediterranean diet supplemented with GABA-producing probiotics, e.g., Bifidobacterium adolescentis PRL2019) on fibromyalgia (FM) severity-particularly pain, sleep quality, anxiety, and depression-using validated questionnaires in female patients with FM and overweight/class I obesity.

Secondary objectives

* Evaluate effects on anthropometric measures, metabolic profile, and body composition. * Assess changes in gut microbiota composition and metabolomic analysis. * Measure neurosteroids with positive allosteric activity on GABA-A or NMDA receptors in saliva and/or plasma. * Exploratory pilot sub-study to quantify brain GABA and glutamate levels through magnetic resonance spectroscopy (MRS) in a subset of patients.

Methods Participants will be recruited from the Rheumatology Unit outpatient clinics of IRCCS Policlinico San Martino Hospital (Genoa). Eligible subjects will be adult women with FM and overweight/obesity, selected through protocol-defined criteria. Enrollment requires written informed consent.

At enrollment (baseline), participants will complete validated questionnaires assessing FM severity (pain, sleep quality, depression, anxiety, bowel function). Data collection will include sociodemographic information, Mediterranean diet adherence through PREDIMED questionnaire, basal metabolic rate, medical and dietary history, smoking status, blood pressure, and recent laboratory results. Stool, blood, and saliva samples will be collected for routine tests, metabolomics, and ELISA-based measurement of neuroactive steroids like cortisol, progesterone, DHEA.

Within 7 days T1, results will be reviewed and eligible participants randomized to one of three groups: hypocaloric ketogenic diet, Mediterranean diet, or Mediterranean diet plus probiotics. Individualized dietary plans will be provided with written and verbal instructions.

Anthropometric measurements (weight, height, BMI, waist circumference, waist-hip ratio) and body composition via bioelectrical impedance analysis BIA will be recorded at T0, T4, T8, and T12, together with biological sample collection.

Pilot MRS sub-study A subset of participants will undergo brain GABA and glutamate assessment through MRI spectroscopy performed on a 3T Siemens - Prisma magnet at the baseline, before dietary treatment and after 4 weeks. Results will be compared with spectra from control subjects screened through medical history to exclude relevant diseases.

The 3 groups in the trial

  • Very Low-Calorie Ketogenic Diet (VLCKD)Treatment being tested

    30 patients in the study will follow a standardised Very Low Calorie Ketogenic Diet (VLCKD). The intervention will be conducted under medical and nutritional supervision for the entire duration of the study through follow-up visits and telephone contact as necessary.

    Treatment: Very Low-Calorie Ketogenic Diet

  • Mediterranean DietTreatment being tested

    30 patients in the study will follow a standardized Mediterranean diet. The intervention will be conducted under medical and nutritional supervision for the entire duration of the study through follow-up visits and telephone contact as necessary.

  • Mediterranean Diet enriched by GABA- producing probioticTreatment being tested

    30 patients in the study will follow a standardised Mediterranea Diet enriched by GABA-producing probiotic. The intervention will be conducted under medical and nutritional supervision for the entire duration of the study through follow-up visits and telephone contact as necessary.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Different Dietary Strategies in the Management of Overweight and Obesity in Patients With Fibromyalgia: Effects on Pain, Disease Severity, Nutritional and Metabolic Profile, Gut Microbiota and Microbial Metabolites, and Brain GABA and Glutamate Levels
Plain-language title
Diets for overweight women living with fibromyalgia, including a probiotic versionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07517757, who can take part
Record updated
30 September 2026