Fibromyalgia Clinical Trials

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Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
İstanbul University-Cerrahpaşa Hospital
RECRUITING
Istanbul
Contact Information
Primary
Tuba Kahraman, Research Assistant
tubasezer@halic.edu.tr
+90 530 642 70 86
Time Frame
Start Date: 2026-03-15
Estimated Completion Date: 2027-02-15
Participants
Target number of participants: 45
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hacettepe University

This content was sourced from clinicaltrials.gov