Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire Revised
研究概览
简要总结
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.
详细描述
This is a single-center, parallel-group, randomized clinical trial with three intervention conditions implemented over an 8-week period. After screening and baseline procedures, participants are assigned in a 1:1:1 ratio using a computer-generated block randomization sequence prepared by an independent researcher not otherwise involved in study conduct. Allocation concealment is maintained using sequentially numbered, opaque, sealed envelopes opened only after confirming eligibility.
Due to the dietary nature of the interventions, participant-level blinding is not feasible. However, biospecimen handling and laboratory analyses are performed on coded (anonymized) samples; laboratory personnel remain blinded to group assignment and time point to minimize measurement bias.
Personalized medical nutrition therapy (MNT) is delivered using a standardized counseling framework with individualized targets. Resting metabolic rate is estimated using the Mifflin-St Jeor equation, and daily energy prescription is derived using physical activity level (PAL). Macro-distribution targets are standardized (10-20% protein, 45-60% carbohydrate, 25-30% fat), with saturated fat <7% of energy and trans fat <1% to align with guidance-based cardiometabolic risk control.
To reduce confounding from background polyphenol exposure, participants are instructed to avoid high-polyphenol red/purple fruits and vegetables according to protocol-defined lists; diet plans are structured as three main meals plus 2-3 snacks, and standardized exchange lists are provided to support adherence.
Hardaliye intervention (product handling and quality assurance): The study beverage is sourced from a traditional producer in Kırklareli and manufactured via controlled spontaneous fermentation without starter culture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hardaliye (200 mL/day) (Other)
Medical Nutrition Therapy
Assigned Interventions:
Medical Nutrition Therapy (MNT) Arm Description: Participants receive individualized MNT; no study beverage is provided.
干预措施: Medical Nutrition Therapy (MNT) (Behavioral)
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.
干预措施: Medical Nutrition Therapy (MNT) (Behavioral)
Hardaliye
Assigned Interventions:
Hardaliye (200 mL/day) Arm Description: Participants consume 200 mL hardaliye once daily and continue usual diet; no MNT is provided.
干预措施: Hardaliye (200 mL/day) (Other)
结局指标
主要结局
Fibromyalgia Impact Questionnaire Revised
时间窗: Baseline to Week 8
Change in FIQR (0-100); lower scores indicate less symptom burden and better function.
Pain Severity (Visual Analog Scale, VAS)
时间窗: 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)
时间窗: 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)
时间窗: Baseline to Week 8
Change in PSQI global score (0-21); lower scores indicate better sleep quality.
Depressive Symptoms (Beck Depression Inventory, BDI)
时间窗: Baseline to Week 8
Change in BDI total score (0-63); lower scores indicate fewer depressive symptoms.
次要结局
- 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)
- Inflammatory biomarkers (TNF-α, IL-6, hs-CRP)(Baseline to Week 8)
- Serum Sirtuin-1(SIRT1)(Baseline to Week 8)
研究者
Tuba Kahraman
Research Assistant
Hacettepe University