The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 40 years old?
Source: NCT07403929, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hacettepe University
- Trial code
- NCT07403929
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients
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 plan) Hardaliye only (usual diet + one 200 mL bottle of hardaliye daily)
Participants will:
Drink 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
Who can join:
Adult women (20-40 years) with doctor-diagnosed fibromyalgia and BMI 25.0-29.9 kg/m² who meet the study's health and medication criteria.
Inclusion: 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: Food allergies; acute infection; antibiotic use within past month or during intervention; 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; Age <20 or >40; BMI ≤24.99 or ≥30.0 kg/m²; Professional athletes; night-shift workers; Use (past 3 months) of dietary supplements; recent weight-loss or special diets (e.g., ketogenic); Pregnancy/lactation; menopause; High recent intake of grape juice/molasses; excess tea/coffee (≥7 cups/day); Adherence <80% to beverage or MNT during run-in/screening.