[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623999":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":57,"collaborators":29,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":29,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":29,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":93,"whyStopped":29,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Hacettepe University","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Medical Nutrition Therapy + Hardaliye","EXPERIMENTAL","Assigned Interventions:\n\nMedical Nutrition Therapy (MNT) Hardaliye (200 mL\u002Fday)\n\nArm Description: Participants receive individualized MNT and consume 200 mL hardaliye once daily during the intervention period.",[13,14],"Behavioral: Medical Nutrition Therapy (MNT)","Other: Hardaliye (200 mL\u002Fday)",{"label":16,"type":10,"description":17,"interventionNames":18},"Medical Nutrition Therapy","Assigned Interventions:\n\nMedical Nutrition Therapy (MNT) Arm Description: Participants receive individualized MNT; no study beverage is provided.",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Hardaliye","Assigned Interventions:\n\nHardaliye (200 mL\u002Fday) Arm Description: Participants consume 200 mL hardaliye once daily and continue usual diet; no MNT is provided.",[14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Medical Nutrition Therapy (MNT)","Individually tailored medical nutrition therapy delivered using a standardized counseling framework, energy prescription derived from predictive equations and physical activity level, with standardized macronutrient targets and follow-up reinforcement per protocol.",[16,9],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Hardaliye (200 mL\u002Fday)","Traditional grape-based fermented beverage dispensed in 200 mL bottles; participants consume 200 mL once daily for the intervention period with standardized intake instructions and product handling.",[20,9],[35],{"name":36,"affiliation":37,"role":38},"Aylin Ayaz, Prof.Dr.","Hacettepe University Nutrition and Dietetics Department","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":44},"Tuba Kahraman, Research Assistant","CONTACT","+90 530 642 70 86","tubasezer@halic.edu.tr",[46],{"facility":47,"status":29,"city":48,"state":48,"zip":49,"country":50,"countryCode":29,"cosmosGeoPoint":51,"geoPoint":56,"contacts":29},"İstanbul University-Cerrahpaşa Hospital","Istanbul","34098","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],28.94966,41.01384,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Tuba Kahraman","Research Assistant","100623999","the-effect-of-fermented-grape-juice-consumption-on-fibromyalgia-patients-100623999",false,"NCT07403929","The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients","Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients","Inclusion Criteria:\n\n* Female, 20-40 years\n* BMI 25.0-29.9 kg\u002Fm²\n* FM per 2016 ACR criteria; abdominal pain\u002Fcramp per SSS sub-item\n* MEDAS ≤5 at screening.\n* Willing to maintain habitual activity and comply with assigned intervention; able to provide informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C20 or \\>40\n* BMI ≤24.99 or ≥30.0 kg\u002Fm²\n* Professional athletes; night-shift workers\n* Food allergies; acute infection; antibiotic use within past month or during intervention.\n* Use (past 3 months) of dietary supplements; recent weight-loss or special diets (e.g., ketogenic).\n* Pregnancy\u002Flactation; menopause.\n* Major hepatic\u002Frenal\u002Fcardiac\u002Fimmune disease; chronic GI diseases; diabetes; CNS disorders; cancer; thyroid disease; severe pulmonary disease. Inflammatory arthritis\u002Fautoimmune disease impacting weight; medications including corticosteroids, estrogens, analgesics\u002Fanti-inflammatories, anti-diabetic or lipid-lowering drugs.\n* Severe psychiatric illness\u002Fsubstance use; heavy alcohol\u002Fsmoking.\n* High recent intake of grape juice\u002Fmolasses; excess tea\u002Fcoffee (≥7 cups\u002Fday).\n* Adherence \\\u003C80% to beverage or MNT during run-in\u002Fscreening.","FEMALE","20 Years","40 Years",{"count":72,"type":73},45,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to learn if a traditional grape-based fermented drink called hardaliye helps treat fibromyalgia in adult women. We will also learn whether adding hardaliye to a personalized nutrition plan works better than using either one alone.\n\nThe main questions are:\n\nDoes diet + hardaliye improve antioxidant status and lower oxidative stress more than diet only or hardaliye only? Does diet + hardaliye lower inflammation (TNF-α, IL-6, hs-CRP) and raise SIRT1 levels? Do these changes relate to less pain and better symptoms (fibromyalgia impact, gut symptoms, sleep, mood)? Are there benefits for weight, waist size, blood pressure, and blood lipids?\n\nHow the groups are compared:\n\nResearchers will compare three groups for 8 weeks:\n\nDiet + Hardaliye (personalized medical nutrition plan + one 200 mL bottle of hardaliye daily) Diet only (personalized medical nutrition plan) Hardaliye only (usual diet + one 200 mL bottle of hardaliye daily)\n\nParticipants will:\n\nDrink one 200 mL bottle of hardaliye each day if assigned to Diet + Hardaliye or Hardaliye only Follow a personalized nutrition plan if assigned to Diet + Hardaliye or Diet only Visit the clinic at the start and end of the study, with brief check-ins around weeks 2, 4, and 6 Give blood samples before and after the 8-week period Complete short questionnaires on pain, fibromyalgia impact, gut symptoms, sleep, and mood Keep simple logs of daily drink intake and diet plan adherence, and report any side effects\n\nWho can join:\n\nAdult women (20-40 years) with doctor-diagnosed fibromyalgia and BMI 25.0-29.9 kg\u002Fm² who meet the study's health and medication criteria.",[79,80,81],"Fibromyalgia","Fibromyalgia (FM)","Fibromyalgia Syndrome, Primary",[83,84,85,86,87,88,89,90,91,92],"fibromyalgia","chronic pain","pain","inflammation","oxidative stress","sirtuin-1","SIRT1","gut microbiota","phytochemicals","nutrition","NOT_YET_RECRUITING","2026-02-07",{"date":96,"type":97},"2026-02-11","ACTUAL",{"date":99,"type":73},"2026-02-15",{"date":101,"type":73},"2027-02-15",{"name":5,"class":6},1]