[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632751":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":49,"responsibleParty":67,"collaborators":71,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":30,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":107,"whyStopped":30,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Universita degli Studi di Genova","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Very Low-Calorie Ketogenic Diet (VLCKD)","EXPERIMENTAL","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.",[13],"Behavioral: Very Low-Calorie Ketogenic Diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Mediterranean Diet","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.",[18],"Behavioral: Mediterranean diet",{"label":20,"type":10,"description":21,"interventionNames":22},"Mediterranean Diet enriched by GABA- producing probiotic","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.",[23],"Behavioral: Mediterranean diet enriched by GABA-producing probiotic",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Very Low-Calorie Ketogenic Diet","The very low calorie ketogenic diet (VLCKD) is a diet characterized by a very low carbohydrate content and reduced calorie intake, while maintaining an adequate amount of protein. In this study, subjects will receive food kits and supplements prepared by SDM, a company belonging to the Pronokal group. The VLCKD involves three different phases of intervention: the 4-week attack phase (phase l), the transition phase (phase Il), and the maintenance phase (phase III). Phase I is characterized by an 800 kcal diet with 1.2 g\u002Fkg\u002Fideal weight of protein, 10-15 g of lipids, and 45-70 g of carbohydrates. Phase Il (four weeks) aims to gradually reintroduce carbohydrates, increase calorie intake and reduce consumption of Pronokal products. Phase Ill involves maintenance through a low-calorie Mediterranean-style diet in line with the other arms interventions, of 1400 kcal\u002Fday for another 4 weeks.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Mediterranean diet","A standardized low-calorie diet of 1400 kcal\u002Fday will be drawn up. The macronutrient breakdown will follow the Reference Intake Levels for Nutrients and Enerav (LARN V edition), providing for: 0.9 g\u002Fday\u002Fkg of ideal body weight of protein, 48% carbohydrates, and 30-35% lipids. The daily calorie breakdown will be: 15% of calories for breakfast, 35-40% for lunch, 30-35% for dinner, and 10% of the remaining calories to be divided into two snacks. Each patient must follow the Mediterranean Diet for the entire duration of the treatment, i.e., 12 weeks, during which any necessary changes will be made to ensure full compliance with the diet plan.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Mediterranean diet enriched by GABA-producing probiotic","Standardized low-calorie diet of 1400 kcal\u002Fday characterized by: 0.9 g\u002Fday\u002Fkg of ideal body weight of protein, 48% carbohydrates, and 30-35% lipids. The daily calorie breakdown will be: 15% of calories for breakfast, 35-40% for lunch, 30-35% for dinner, and 10% of the remaining calories to be divided into two snacks. This diet will also be enriched with GABA-producing probiotics such as Bifidobacterium adolescentis PRL2019 (20 CFU\u002Fday) present in Gabapral produced by Pharmextracta S.p.A.",[20],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Alberto Sulli, Professor","CONTACT","010-35338710","alberto.sulli@unige.it",{"name":46,"role":42,"phone":47,"phoneExt":30,"email":48},"Livia Pisciotta, Professor","010-3538689","livia.pisciotta@unige.it",[50],{"facility":51,"status":30,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Internal and Medical Specialities (university of Genoa)","Genova","16132","Italy","IT",{"type":57,"coordinates":58},"Point",[59,60],11.87211,45.21604,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":65,"phoneExt":30,"email":66},"Edoardo Giovanni Giannini, Professor","(+39) 010 3538975","dirdimi@unige.it",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","SULLI ALBERTO","Professor",[72,74],{"name":73,"class":6},"Ospedale Policlinico San Martino",{"name":75,"class":6},"Istituto Giannina Gaslini","100632751","dietary-strategies-for-the-treatment-of-fibromyalgia-in-overweight-and-obese-patients-100632751",false,"NCT07517757","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","FIBRODIET","Inclusion Criteria:\n\n* Adult female patients with fibromyalgia, aged ≤ 65 years, who are overweight or obese (BMI 24.9 \\\u003C ≤34.9 kg\u002Fm2);\n* Patients able to independently provide their written informed consent to participate in the study;\n* Patients motivated to participate in the project and able to independently manage the dietary plans provided for in the study.\n\nExclusion Criteria:\n\n* Lack of signature on informed consent form\n* Age \\\u003C 18 and \\> 65 years\n* Male gender\n* 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\u002For 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.\n* Use of prebiotics and\u002For probiotics not included in the study, or other dietary supplements in the month prior to enrollment\n* Antibiotic treatment less than 3 months prior to enrollment\n* Infections at the time of enrollment or any chronic gastrointestinal disorder (e.g., Crohn's disease)\n* Significant eating problems (e.g., dysphagia).","FEMALE","18 Years","65 Years",{"count":88,"type":89},90,"ESTIMATED","INTERVENTIONAL",[92],"NA","Spontaneous, non-sponsored, interventional, controlled, randomized, parallel-arm clinical study.\n\nPrimary 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\u002Fclass I obesity.\n\nSecondary objectives\n\n* Evaluate effects on anthropometric measures, metabolic profile, and body composition.\n* Assess changes in gut microbiota composition and metabolomic analysis.\n* Measure neurosteroids with positive allosteric activity on GABA-A or NMDA receptors in saliva and\u002For plasma.\n* Exploratory pilot sub-study to quantify brain GABA and glutamate levels through magnetic resonance spectroscopy (MRS) in a subset of patients.\n\nMethods 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\u002Fobesity, selected through protocol-defined criteria. Enrollment requires written informed consent.\n\nAt 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.\n\nWithin 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.\n\nAnthropometric 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.\n\nPilot 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.",[95],"Fibromyalgia (FM)",[97,98,99,100,101,102,103,104,105,106],"Fibromyalgia","questionnaires","dietary intervention","obesity","gut microbiota","probiotics","gut-brain-axis","GABA","glutamate","magnetic resonance spectroscopy","NOT_YET_RECRUITING","2026-04-03",{"date":110,"type":111},"2026-04-08","ACTUAL",{"date":113,"type":89},"2026-04",{"date":115,"type":89},"2028-06",{"name":5,"class":6},1]