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Dietary Strategies for the Treatment of Fibromyalgia in Overweight and Obese Patients

RecruitingNAAges 18 Years - 65 YearsFemaleUniversita degli Studi di Genova
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In plain words

What the trial is, and whether it could suit you

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 spectrosco

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult female patients with fibromyalgia, aged โ‰ค 65 years, who are overweight or obese (BMI 24.9 \< โ‰ค34.9 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).
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What it tests

  • Very Low-Calorie Ketogenic Diet
  • Mediterranean diet
  • Mediterranean diet enriched by GABA-producing probiotic
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Where

1 site
Department of Internal and Medical Specialities (university of Genoa)
Genova, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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