Does hardaliye help fibromyalgia when added to a personalized diet?
Official title: Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients
Run by Hacettepe University · NCT07403929 · Data updated 2026-11-12
This study tests whether a traditional grape-based drink called hardaliye, used with a personalized diet, can improve symptoms and inflammation in adult women with fibromyalgia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 45 (estimated) |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | March 15, 2026 |
| Main results expected | December 15, 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT07403929 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 20-40 with fibromyalgia and BMI 25.0-29.9 kg/m² who can adhere to dietary interventions and provide consent.
✕Probably not a fit
Individuals who do not experience changes in inflammation or oxidative stress may see no symptom improvement from these interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, three-arm, parallel-group randomized trial lasting 8 weeks. Participants are women aged 20-40 with fibromyalgia and overweight BMI, assigned to diet plus hardaliye, diet alone, or hardaliye alone. The diet is a standardized medical nutrition therapy designed to meet cardiometabolic targets, while hardaliye is provided as a 200 mL daily beverage; participants are not blinded to treatment but samples are analyzed by blinded lab personnel. Primary outcomes explore changes in antioxidant status and oxidative stress, with secondary outcomes including inflammatory markers (TNF-α, IL-6, hs-CRP), SIRT1 levels, and patient-reported symptoms such as pain, function, gut symptoms, sleep, and mood. Additional measures include weight, waist circumference, blood pressure, and lipids. Randomization uses a computer-generated block sequence with allocation concealment, and codified biospecimens help minimize bias in analyses.
Why it matters
Potential benefit: If successful, this approach could offer a dietary strategy that improves pain and inflammatory markers in fibromyalgia patients.
How similar studies have gone: Prior work in polyphenol-rich components suggests potential benefits, but combining hardaliye with a personalized diet in fibromyalgia is relatively novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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İstanbul University-Cerrahpaşa Hospital
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Tuba Kahraman, Research Assistant
- Email: tubasezer@halic.edu.tr
- Phone: +90 530 642 70 86
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.