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The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients

RecruitingNAAges 20 Years - 40 YearsFemaleHacettepe University
NCT07403929 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The main questions are: Does 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? How the groups are compared: Researchers will compare three groups for 8 weeks: Diet + Hardaliye (personalized medical nutrition plan + one 200 mL bottle of hardaliye daily) Diet only (personalized medical nutrition pla

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female, 20-40 years * BMI 25.0-29.9 kg/m² * FM per 2016 ACR criteria; abdominal pain/cramp per SSS sub-item * MEDAS ≤5 at screening. * Willing to maintain habitual activity and comply with assigned intervention; able to provide informed consent. Exclusion Criteria: * Age \<20 or \>40 * BMI ≤24.99 or ≥30.0 kg/m² * Professional athletes; night-shift workers * Food allergies; acute infection; antibiotic use within past month or during intervention. * Use (past 3 months) of dietary supplements; recent weight-loss or special diets (e.g., ketogenic). * Pregnancy/lactation; menopause. * Major hepatic/renal/cardiac/immune disease; chronic GI diseases; diabetes; CNS disorders; cancer; thyroid disease; severe pulmonary disease. Inflammatory arthritis/autoimmune disease impacting weight; medications including corticosteroids, estrogens, analgesics/anti-inflammatories, anti-diabetic or lipid-lowering drugs. * Severe psychiatric illness/substance use; heavy alcohol/smoking. * High recent intake of grape juice/molasses; excess tea/coffee (≥7 cups/day). * Adherence \<80% to beverage or MNT during run-in/screening.
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What it tests

  • Medical Nutrition Therapy (MNT)
  • Hardaliye (200 mL/day)
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Where

1 site
İstanbul University-Cerrahpaşa Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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