An interventional study of Medical Nutrition Therapy (MNT) and Hardaliye (200 mL/day) in Fibromyalgia, Fibromyalgia (FM) and Fibromyalgia Syndrome, Primary, sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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.
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.
Hardaliye is dispensed in 200 mL bottles and distributed weekly under cold-chain conditions; participants are instructed to consume the beverage daily within a consistent intake window (16:00-16:30) to standardize exposure timing.
To ensure batch-to-batch consistency, each production batch undergoes predefined acceptance checks (°Brix, pH, and titratable acidity), and key compositional markers are measured post-bottling (total phenolics via Folin-Ciocalteu, total monomeric anthocyanins via pH-differential method, and antioxidant capacity via ABTS-based TEAC). Analytical repeatability is monitored (replicates/parallel runs; CV target \<10% with repeat testing if unmet).
Batches outside acceptance ranges (e.g., °Brix 20.5-21.8; pH 3.50-4.00; acidity 0.68-0.75 g/100 mL; and protocol-defined total phenolic/anthocyanin targets) are excluded from participant distribution.
Where relevant, chromatographic confirmation (HPLC-DAD) is used to verify the phenolic profile of the study product and support linkage of total phenolic estimates to compound-level composition.
Participants complete an initial screening visit followed by a baseline (Day 0) visit and an end-of-intervention (Week 8) visit, with brief interim check-ins at Weeks 2, 4, and 6 for adherence review and systematic safety monitoring. Interim contacts include beverage count/log review, reinforcement of dietary counseling where applicable, and adverse event solicitation/documentation.
Adherence is operationalized as ≥80% compliance with the assigned beverage intake and/or nutrition therapy targets; intake and adherence are captured using simple participant logs reviewed at each contact.
Dietary intake is assessed using structured food records collected at multiple time points (7-day records at baseline, Week 4, and Week 8; and additional 3-day records during specified weeks) to quantify energy and nutrient intake and to support adherence monitoring. Nutrient analyses are performed using BeBIS software and interpreted against national reference intakes.
Dietary polyphenol exposure is estimated using Phenol-Explorer (v3.6) to derive total polyphenols and relevant subclasses; an antioxidant diet quality score (DAQS) is calculated based on intake of key antioxidant nutrients. Physical activity is monitored via 24-hour recall on diary days, and PAL is derived using activity-specific PAR values combined with Mifflin-St Jeor BMR estimates to support stability of lifestyle exposure during follow-up.
Fasting venous blood is collected at baseline and Week 8 and processed according to institutional standard operating procedures (timing, centrifugation, aliquoting, storage). Samples are labeled with coded identifiers to preserve analytical blinding, and assays are performed following validated methods and kit instructions with internal QC steps documented prospectively.
Data are captured in structured case report forms and reconciled against visit checklists, distribution records, and participant logs. Primary analyses follow an intention-to-treat approach. Group differences in change over time are evaluated using repeated-measures modeling (e.g., linear mixed-effects models including group, time, and group×time interaction), with prespecified sensitivity analyses based on adherence and protocol deviations; missing-data handling and multiplicity procedures are defined in the statistical analysis plan.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Assigned Interventions: Medical Nutrition Therapy (MNT) Arm Description: Participants receive individualized MNT; no study beverage is provided.
Behavioral: Medical Nutrition Therapy (MNT)
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)
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.
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.
Fibromyalgia Impact Questionnaire Revised
Change in FIQR (0-100); lower scores indicate less symptom burden and better function.
Time frame: Baseline to Week 8
Pain Severity (Visual Analog Scale, VAS)
Change in 0-10 cm VAS for average pain; lower scores reflect less pain.
Time frame: 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
Time frame: Baseline to Week 8
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Change in PSQI global score (0-21); lower scores indicate better sleep quality.
Time frame: Baseline to Week 8
Depressive Symptoms (Beck Depression Inventory, BDI)
Change in BDI total score (0-63); lower scores indicate fewer depressive symptoms.
Time frame: Baseline to Week 8
Total Antioxidant Status (TAS; μmol Trolox eq/L)
Change in circulating antioxidant capacity; higher values suggest stronger systemic antioxidant defense.
Time frame: Baseline to Week 8
Total Oxidant Status (TOS; μmol H₂O₂ eq/L)
Change in cumulative oxidant load; lower values indicate reduced oxidative pressure.
Time frame: Baseline to Week 8
Oxidative Stress Index (OSI = TOS×100 / TAS)
Ratio index of oxidant burden to antioxidant capacity; lower values denote better redox balance.
Time frame: Baseline to Week 8
Plasma Malondialdehyde (MDA; TBARS method)
Change in lipid peroxidation marker; lower levels indicate less oxidative membrane damage.
Time frame: Baseline to Week 8
Serum 8-Hydroxy-2'-deoxyguanosine (8-OHdG)
Change in DNA oxidative damage marker; lower concentrations suggest reduced nucleic acid oxidation.
Time frame: Baseline to Week 8
Inflammatory biomarkers (TNF-α, IL-6, hs-CRP)
Changes in systemic inflammation; reductions indicate attenuation of low-grade inflammatory activity.
Time frame: Baseline to Week 8
Serum Sirtuin-1(SIRT1)
Change in SIRT1 concentration (ELISA); higher levels are consistent with enhanced cellular stress-response signaling.
Time frame: Baseline to Week 8
Body Weight
Body weight measured in light clothing without shoes using a calibrated scale. Units: kilograms (kg). Higher values indicate greater body mass.
Time frame: Baseline to Week 8
Height
Standing height measured without shoes using a calibrated stadiometer. Units: centimeters (cm). Height is collected primarily to compute BMI (kg/m²). Higher values indicate greater stature.
Time frame: Baseline to Week 8
Body Mass Index (BMI)
BMI calculated as weight (kg) / height (m²) using measured weight and height. Units: kg/m². Higher values indicate higher adiposity-related risk.
Time frame: Baseline to Week 8
Waist Circumference
Waist circumference measured at a standardized anatomical site using a non-elastic tape. Units: centimeters (cm). Higher values indicate greater central adiposity.
Time frame: Baseline to Week 8
Waist-to-Hip Ratio (WHR)
WHR calculated as waist circumference (cm) / hip circumference (cm) from standardized tape measurements. Units: ratio (unitless). Higher values indicate greater central fat distribution.
Time frame: Baseline to Week 8
Systolic Blood Pressure (SBP)
Seated systolic blood pressure measured after rest using a validated device per standardized procedure. Units: mmHg. Higher values indicate higher systolic pressure.
Time frame: Baseline to Week 8
Diastolic Blood Pressure (DBP)
Seated diastolic blood pressure measured after rest using a validated device per standardized procedure. Units: mmHg. Higher values indicate higher diastolic pressure.
Time frame: Baseline to Week 8
Lipid Profile (total cholesterol, HDL-C, LDL-C, triglycerides)
Changes indicate potential effects on atherogenic risk.
Time frame: Baseline to Week 8
Dietary Polyphenol Intake (Phenol-Explorer-based total and subclasses)
Estimated change in total/flavonoids/phenolic acids/flavanols/lignans; higher intake supports exposure to bioactive compounds.
Time frame: Baseline to Week 8
Dietary Antioxidant Quality Score (DAQS)
Description: Change in Dietary Antioxidant Quality Score (DAQS), a unitless composite score ranging from 0 to 5 derived from dietary intakes of vitamins A, C, and E, and the minerals zinc and selenium. For each nutrient, participants receive 1 point if their intake is ≥ 2/3 of the age- and sex-specific Recommended Dietary Allowance (RDA) / Dietary Reference Intake (DRI), and 0 points otherwise. Points are summed across the 5 nutrients (minimum 0, maximum 5). Higher DAQS indicates better dietary antioxidant quality (more adequate antioxidant-related nutrient intake), whereas lower scores indicate poorer dietary antioxidant quality.
Time frame: Baseline to Week 8
PDFs hosted by the registry, ClinicalTrials.gov.
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Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 9 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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