The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Hardaliye (200 mL/day): 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 summary

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.

Eligibility

Primary outcome measure(s)

• Fibromyalgia Impact Questionnaire Revised — Baseline to Week 8
  Change in FIQR (0-100); lower scores indicate less symptom burden and better function.
• Pain Severity (Visual Analog Scale, VAS) — Baseline to Week 8
  Change in 0-10 cm VAS for average pain; lower scores reflect less pain.
• Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale, GSRS) — Baseline to Week 8
  Change in Gastrointestinal Symptom Rating Scale (GSRS) total score and subscale scores (abdominal pain, reflux, diarrhea, dyspepsia/indigestion, constipation). The GSRS includes 15 items, each rated for the past week on a 7-point scale (1 = no discomfort, 7 = very severe discomfort). Higher scores indicate worse gastrointestinal symptoms and lower scores indicate fewer/milder symptoms. Total score (sum of 15 items): 15-105 Abdominal pain subscale (Items 1, 4, 5; sum): 3-21 Reflux subscale (Items 2, 3; sum): 2-14 Dyspepsia/Indigestion subscale (Items 6, 7, 8, 9; sum): 4-28 Diarrhea subscale (Items 11, 12, 14; sum): 3-21 Constipation subscale (Items 10, 13, 15; sum): 3-21
• Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) — Baseline to Week 8
  Change in PSQI global score (0-21); lower scores indicate better sleep quality.
• Depressive Symptoms (Beck Depression Inventory, BDI) — Baseline to Week 8
  Change in BDI total score (0-63); lower scores indicate fewer depressive symptoms.

Trial sites (1)

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