The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients

NCT07403929 | Recruiting

• 1 other identifier: 1422809
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia; Fibromyalgia (FM); Fibromyalgia Syndrome, Primary

Keywords

fibromyalgia; chronic pain; pain; inflammation; oxidative stress; sirtuin-1; SIRT1; gut microbiota; phytochemicals; nutrition

Outcome Measures

Primary Outcomes (5)

• Fibromyalgia Impact Questionnaire Revised

  Change in FIQR (0-100); lower scores indicate less symptom burden and better function.

  Baseline to Week 8

• Pain Severity (Visual Analog Scale, VAS)

  Change in 0-10 cm VAS for average pain; lower scores reflect less pain.

  Baseline to Week 8

• Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale, GSRS)

  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

  Baseline to Week 8

• Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

  Change in PSQI global score (0-21); lower scores indicate better sleep quality.

  Baseline to Week 8

• Depressive Symptoms (Beck Depression Inventory, BDI)

  Change in BDI total score (0-63); lower scores indicate fewer depressive symptoms.

  Baseline to Week 8

Secondary Outcomes (7)

• Total Antioxidant Status (TAS; μmol Trolox eq/L)

  Baseline to Week 8

• Total Oxidant Status (TOS; μmol H₂O₂ eq/L)

  Baseline to Week 8

• Oxidative Stress Index (OSI = TOS×100 / TAS)

  Baseline to Week 8

• Plasma Malondialdehyde (MDA; TBARS method)

  Baseline to Week 8

• Serum 8-Hydroxy-2'-deoxyguanosine (8-OHdG)

  Baseline to Week 8

Other Outcomes (10)

• Body Weight

  Baseline to Week 8

• Height

  Baseline to Week 8

• Body Mass Index (BMI)

  Baseline to Week 8

Study Arms (3)

Medical Nutrition Therapy + Hardaliye

EXPERIMENTAL

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.

Behavioral: Medical Nutrition Therapy (MNT); Other: Hardaliye (200 mL/day)

Medical Nutrition Therapy

EXPERIMENTAL

Assigned Interventions: Medical Nutrition Therapy (MNT) Arm Description: Participants receive individualized MNT; no study beverage is provided.

Behavioral: Medical Nutrition Therapy (MNT)

Hardaliye

EXPERIMENTAL

Assigned Interventions: Hardaliye (200 mL/day) Arm Description: Participants consume 200 mL hardaliye once daily and continue usual diet; no MNT is provided.

Other: Hardaliye (200 mL/day)

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.

Medical Nutrition Therapy; Medical Nutrition Therapy + Hardaliye

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.

Hardaliye; Medical Nutrition Therapy + Hardaliye

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

İstanbul University-Cerrahpaşa Hospital

Istanbul, Istanbul, 34098, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Pain; Inflammation

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Aylin Ayaz, Prof.Dr.

  Hacettepe University Nutrition and Dietetics Department

  STUDY DIRECTOR

Central Study Contacts

Tuba Kahraman, Research Assistant

CONTACT

+90 530 642 70 86; tubasezer@halic.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: February 11, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)