Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients
Phase: NA
Conditions: Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome, Primary
Sponsor: Hacettepe University

STUDY PROTOCOL 
 
Official Title: The Effect of Fermented Grape Juice Consumption on 
Fibromyalgia Patients 
NCT Number: NCT ID not yet assigned 
Unique Protocol ID: 1422809 
Document Date: 22 September 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Outcome Measures 
Primary Outcome Measures 
1. Fibromyalgia Impact (FIQR) 
Change in Fibromyalgia Impact Questionnaire–Revised (FIQR) total score (0–100); lower scores 
indicate reduced symptom burden. 
Time Frame: Baseline to Week 8 
2. Pain Severity (VAS) 
Change in average pain intensity assessed by a 0–10 cm Visual Analog Scale; lower scores 
indicate less pain. 
Time Frame: Baseline to Week 8 
3. Gastrointestinal Symptoms (GSRS) 
Change in Gastrointestinal Symptom Rating Scale (GSRS) total score and subscale scores; higher 
scores indicate worse symptoms. 
Time Frame: Baseline to Week 8 
4. Sleep Quality (PSQI) 
Change in Pittsburgh Sleep Quality Index (PSQI) global score (0–21); lower scores indicate 
better sleep quality. 
Time Frame: Baseline to Week 8 
5. Depressive Symptoms (BDI) 
Change in Beck Depression Inventory (BDI) total score (0–63); lower scores indicate fewer 
depressive symptoms. 
Time Frame: Baseline to Week 8 
Secondary Outcome Measures 
6. Total Antioxidant Status (TAS) 
Change in circulating total antioxidant capacity; higher values indicate improved antioxidant 
defense. 
Time Frame: Baseline to Week 8 
 
 

7. Total Oxidant Status (TOS) 
Change in cumulative oxidant load; lower values indicate reduced oxidative burden. 
Time Frame: Baseline to Week 8 
8. Oxidative Stress Index (OSI) 
Change in OSI (TOS × 100 / TAS); lower values indicate improved redox balance. 
Time Frame: Baseline to Week 8 
9. Oxidative Damage Markers 
Change in plasma malondialdehyde (MDA) and serum 8-hydroxy-2′-deoxyguanosine (8-OHdG). 
Time Frame: Baseline to Week 8 
10. Inflammatory Biomarkers 
Change in TNF-α, IL-6, and hs-CRP concentrations. 
Time Frame: Baseline to Week 8 
11. Serum Sirtuin-1 (SIRT1) 
Change in circulating SIRT1 levels measured by ELISA. 
Time Frame: Baseline to Week 8 
Other Pre-specified Outcome Measures 
12. Anthropometric and Cardiometabolic Measures 
Changes in body weight, BMI, waist circumference, waist-to-hip ratio, systolic and diastolic 
blood pressure, and lipid profile. 
Time Frame: Baseline to Week 8 
13. Dietary Measures 
Changes in dietary polyphenol intake (Phenol-Explorer–based) and Dietary Antioxidant Quality 
Score (DAQS). 
Time Frame: Baseline to Week 8 
The research protocol is summarized in Figure 1. 
 
 

 
 
 
 
 
 
Figure 1. Study Flowchart