The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients

Sponsor
Hacettepe University
Study ID
NCT07403929
Status
Not Yet Recruiting

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Conditions

  • Fibromyalgia
  • Fibromyalgia (FM)
  • Fibromyalgia Syndrome, Primary

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Medical Nutrition Therapy (MNT) — BEHAVIORAL
    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.
  • Hardaliye (200 mL/day) — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 11, 2026
Start date
Feb 15, 2026
Status verified
Feb 2026
Primary completion
Dec 15, 2026
Completion
Feb 15, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Medical Nutrition Therapy + Hardaliye
    Assigned Interventions: Medical Nutrition Therapy (MNT) Hardaliye (200 mL/day) Arm Description: Participants receive individualized MNT and consume 200 mL hardaliye once daily during the intervention period.
  • Experimental: Medical Nutrition Therapy
    Assigned Interventions: Medical Nutrition Therapy (MNT) Arm Description: Participants receive individualized MNT; no study beverage is provided.
  • Experimental: Hardaliye
    Assigned Interventions: Hardaliye (200 mL/day) Arm Description: Participants consume 200 mL hardaliye once daily and continue usual diet; no MNT is provided.

Primary Outcome Measure

Fibromyalgia Impact Questionnaire Revised [ Time Frame: Baseline to Week 8 ]

Central Contacts

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