NCT07517757Recruiting
Dietary Strategies for the Treatment of Fibromyalgia in Overweight and Obese Patients
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
Spontaneous, non-sponsored, interventional, controlled, randomized, parallel-arm clinical study. 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 11 Mar 2026
- Start date
- 10 Apr 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Universita degli Studi di Genova
- Diseases
- Obesity
- NCT number
- NCT07517757
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 10 Apr 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Infections at the time of enrollment or any chronic gastrointestinal disorder (e.g., Crohn's disease)
Age
- Age \< 18 and \> 65 years
Other
- Lack of signature on informed consent form
- Male gender
- Significant eating problems (e.g., dysphagia).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Internal and Medical Specialities (university of Genoa) Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.