FibromyalgiaNCT07403929
The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients
A study testing Medical Nutrition Therapy (MNT) and Hardaliye (200 mL/day) in people with Fibromyalgia and Fibromyalgia (FM), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome, Primary
- What is being tested?
- Medical Nutrition Therapy (MNT) and Hardaliye (200 mL/day)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul University-Cerrahpaşa Hospital
Istanbul, Istanbul, 34098
Tuba Kahraman, Research Assistant, +90 530 642 70 86, tubasezer@halic.edu.tr
About this study
Official title: Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Medical Nutrition Therapy (MNT), Hardaliye (200 mL/day)
- Keywords
- fibromyalgia, chronic pain, pain, inflammation, oxidative stress, sirtuin-1, SIRT1, gut microbiota, phytochemicals, nutrition
- Medical subject headings
- Fibromyalgia, Chronic Pain, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Nutrition Therapy (MNT)Behavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Hardaliye (200 mL/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire Revised
Change in FIQR (0-100); lower scores indicate less symptom burden and better function.
Measured: Baseline to Week 8
Pain Severity (Visual Analog Scale, VAS)
Change in 0-10 cm VAS for average pain; lower scores reflect less pain.
Measured: 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
Measured: Baseline to Week 8
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Change in PSQI global score (0-21); lower scores indicate better sleep quality.
Measured: Baseline to Week 8
Depressive Symptoms (Beck Depression Inventory, BDI)
Change in BDI total score (0-63); lower scores indicate fewer depressive symptoms.
Measured: Baseline to Week 8
Secondary outcomes (7)
Total Antioxidant Status (TAS; μmol Trolox eq/L)
Change in circulating antioxidant capacity; higher values suggest stronger systemic antioxidant defense.
Measured: Baseline to Week 8
Total Oxidant Status (TOS; μmol H₂O₂ eq/L)
Change in cumulative oxidant load; lower values indicate reduced oxidative pressure.
Measured: 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.
Measured: Baseline to Week 8
Plasma Malondialdehyde (MDA; TBARS method)
Change in lipid peroxidation marker; lower levels indicate less oxidative membrane damage.
Measured: Baseline to Week 8
Serum 8-Hydroxy-2'-deoxyguanosine (8-OHdG)
Change in DNA oxidative damage marker; lower concentrations suggest reduced nucleic acid oxidation.
Measured: Baseline to Week 8
Inflammatory biomarkers (TNF-α, IL-6, hs-CRP)
Changes in systemic inflammation; reductions indicate attenuation of low-grade inflammatory activity.
Measured: Baseline to Week 8
Serum Sirtuin-1(SIRT1)
Change in SIRT1 concentration (ELISA); higher levels are consistent with enhanced cellular stress-response signaling.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Mar 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (96)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Kahraman, Hacettepe University
- Investigators
- Aylin Ayaz, Prof.Dr., Study director, Hacettepe University Nutrition and Dietetics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403929
- Sponsor's protocol ID
- 1422809
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I haven't started working on it yet and made progress.
Publications
Erel O. A new automated colorimetric method for measuring total oxidant status. Clin Biochem. 2005 Dec;38(12):1103-11. doi: 10.1016/j.clinbiochem.2005.08.008. Epub 2005 Oct 7.
PubMed 16214125Erel O. A novel automated method to measure total antioxidant response against potent free radical reactions. Clin Biochem. 2004 Feb;37(2):112-9. doi: 10.1016/j.clinbiochem.2003.10.014.
PubMed 14725941Al-Aubaidy HA, Jelinek HF. Oxidative stress and triglycerides as predictors of subclinical atherosclerosis in prediabetes. Redox Rep. 2014 Mar;19(2):87-91. doi: 10.1179/1351000213Y.0000000080. Epub 2014 Jan 13.
PubMed 24520969Jentzsch AM, Bachmann H, Furst P, Biesalski HK. Improved analysis of malondialdehyde in human body fluids. Free Radic Biol Med. 1996;20(2):251-6. doi: 10.1016/0891-5849(95)02043-8.
PubMed 8746446Gerrior S, Juan W, Basiotis P. An easy approach to calculating estimated energy requirements. Prev Chronic Dis. 2006 Oct;3(4):A129. Epub 2006 Sep 15.
PubMed 16978504Bekar C, Goktas Z. Validation of the 14-item mediterranean diet adherence screener. Clin Nutr ESPEN. 2023 Feb;53:238-243. doi: 10.1016/j.clnesp.2022.12.026. Epub 2022 Dec 29.
PubMed 36657918Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.
PubMed 22905215Rivas A, Romero A, Mariscal-Arcas M, Monteagudo C, Lopez G, Lorenzo ML, Ocana-Peinado FM, Olea-Serrano F. Association between dietary antioxidant quality score (DAQs) and bone mineral density in Spanish women. Nutr Hosp. 2012 Nov-Dec;27(6):1886-93. doi: 10.3305/nh.2012.27.6.6039.
PubMed 23588435Tur JA, Serra-Majem L, Romaguera D, Pons A. Does the diet of the Balearic population, a Mediterranean type diet, still provide adequate antioxidant nutrient intakes? Eur J Nutr. 2005 Jun;44(4):204-13. doi: 10.1007/s00394-004-0512-0. Epub 2004 Jul 7.
PubMed 15309419Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3.
PubMed 10534586Ediz L, Hiz O, Toprak M, Tekeoglu I, Ercan S. The validity and reliability of the Turkish version of the Revised Fibromyalgia Impact Questionnaire. Clin Rheumatol. 2011 Mar;30(3):339-46. doi: 10.1007/s10067-010-1546-8. Epub 2010 Aug 12.
PubMed 20703890Sohrab G, Ebrahimof S, Sotoudeh G, Neyestani TR, Angoorani P, Hedayati M, Siasi F. Effects of pomegranate juice consumption on oxidative stress in patients with type 2 diabetes: a single-blind, randomized clinical trial. Int J Food Sci Nutr. 2017 Mar;68(2):249-255. doi: 10.1080/09637486.2016.1229760. Epub 2016 Sep 16.
PubMed 27633135Park M, Choi J, Lee HJ. Flavonoid-Rich Orange Juice Intake and Altered Gut Microbiome in Young Adults with Depressive Symptom: A Randomized Controlled Study. Nutrients. 2020 Jun 18;12(6):1815. doi: 10.3390/nu12061815.
PubMed 32570775Park YK, Lee SH, Park E, Kim JS, Kang MH. Changes in antioxidant status, blood pressure, and lymphocyte DNA damage from grape juice supplementation. Ann N Y Acad Sci. 2009 Aug;1171:385-90. doi: 10.1111/j.1749-6632.2009.04907.x.
PubMed 19723080Ghoochani N, Karandish M, Mowla K, Haghighizadeh MH, Jalali MT. The effect of pomegranate juice on clinical signs, matrix metalloproteinases and antioxidant status in patients with knee osteoarthritis. J Sci Food Agric. 2016 Oct;96(13):4377-81. doi: 10.1002/jsfa.7647. Epub 2016 Feb 22.
PubMed 26804926
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT07403929
- Acronym / sponsor ID
- 1422809
- Keywords
- fibromyalgia, chronic pain, pain, inflammation, oxidative stress, sirtuin-1, SIRT1, gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical Nutrition Therapy + Hardaliye | Experimental | Behavioral: Medical Nutrition Therapy (MNT), Other: Hardaliye (200 mL/day)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. |
| Medical Nutrition Therapy | Experimental | Behavioral: Medical Nutrition Therapy (MNT)Assigned Interventions: Medical Nutrition Therapy (MNT) Arm Description: Participants receive individualized MNT; no study beverage is provided. |
| Hardaliye | Experimental | Other: Hardaliye (200 mL/day)Assigned Interventions: Hardaliye (200 mL/day) Arm Description: Participants consume 200 mL hardaliye once daily and continue usual diet; no MNT is provided. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Nutrition Therapy (MNT)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. | Behavioural | Medical Nutrition Therapy, Medical Nutrition Therapy + Hardaliye |
| Hardaliye (200 mL/day)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. | Other | Hardaliye, Medical Nutrition Therapy + Hardaliye |
Primary outcome
Fibromyalgia Impact Questionnaire Revised
Time frame: Baseline to Week 8
Change in FIQR (0-100); lower scores indicate less symptom burden and better function.
Pain Severity (Visual Analog Scale, VAS)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to Week 8
Change in PSQI global score (0-21); lower scores indicate better sleep quality.
Depressive Symptoms (Beck Depression Inventory, BDI)
Time frame: Baseline to Week 8
Change in BDI total score (0-63); lower scores indicate fewer depressive symptoms.
7 secondary outcomes
Total Antioxidant Status (TAS; μmol Trolox eq/L)
Time frame: Baseline to Week 8
Total Oxidant Status (TOS; μmol H₂O₂ eq/L)
Time frame: Baseline to Week 8
Oxidative Stress Index (OSI = TOS×100 / TAS)
Time frame: Baseline to Week 8
Plasma Malondialdehyde (MDA; TBARS method)
Time frame: Baseline to Week 8
Serum 8-Hydroxy-2'-deoxyguanosine (8-OHdG)
Time frame: Baseline to Week 8
Inflammatory biomarkers (TNF-α, IL-6, hs-CRP)
Time frame: Baseline to Week 8
Serum Sirtuin-1(SIRT1)
Time frame: Baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 16214125Erel O. A new automated colorimetric method for measuring total oxidant status. Clin Biochem. 2005 Dec;38(12):1103-11. doi: 10.1016/j.clinbiochem.2005.08.008. Epub 2005 Oct 7.
- Background: PubMed 14725941Erel O. A novel automated method to measure total antioxidant response against potent free radical reactions. Clin Biochem. 2004 Feb;37(2):112-9. doi: 10.1016/j.clinbiochem.2003.10.014.
- Background: PubMed 24520969Al-Aubaidy HA, Jelinek HF. Oxidative stress and triglycerides as predictors of subclinical atherosclerosis in prediabetes. Redox Rep. 2014 Mar;19(2):87-91. doi: 10.1179/1351000213Y.0000000080. Epub 2014 Jan 13.
- Background: PubMed 8746446Jentzsch AM, Bachmann H, Furst P, Biesalski HK. Improved analysis of malondialdehyde in human body fluids. Free Radic Biol Med. 1996;20(2):251-6. doi: 10.1016/0891-5849(95)02043-8.
- Background: PubMed 16978504Gerrior S, Juan W, Basiotis P. An easy approach to calculating estimated energy requirements. Prev Chronic Dis. 2006 Oct;3(4):A129. Epub 2006 Sep 15.
- Background: PubMed 36657918Bekar C, Goktas Z. Validation of the 14-item mediterranean diet adherence screener. Clin Nutr ESPEN. 2023 Feb;53:238-243. doi: 10.1016/j.clnesp.2022.12.026. Epub 2022 Dec 29.
- Background: PubMed 22905215Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.
- Background: PubMed 23588435Rivas A, Romero A, Mariscal-Arcas M, Monteagudo C, Lopez G, Lorenzo ML, Ocana-Peinado FM, Olea-Serrano F. Association between dietary antioxidant quality score (DAQs) and bone mineral density in Spanish women. Nutr Hosp. 2012 Nov-Dec;27(6):1886-93. doi: 10.3305/nh.2012.27.6.6039.
- Background: PubMed 15309419Tur JA, Serra-Majem L, Romaguera D, Pons A. Does the diet of the Balearic population, a Mediterranean type diet, still provide adequate antioxidant nutrient intakes? Eur J Nutr. 2005 Jun;44(4):204-13. doi: 10.1007/s00394-004-0512-0. Epub 2004 Jul 7.
- Background: PubMed 10534586Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3.
- Background: PubMed 20703890Ediz L, Hiz O, Toprak M, Tekeoglu I, Ercan S. The validity and reliability of the Turkish version of the Revised Fibromyalgia Impact Questionnaire. Clin Rheumatol. 2011 Mar;30(3):339-46. doi: 10.1007/s10067-010-1546-8. Epub 2010 Aug 12.
- Background: PubMed 27633135Sohrab G, Ebrahimof S, Sotoudeh G, Neyestani TR, Angoorani P, Hedayati M, Siasi F. Effects of pomegranate juice consumption on oxidative stress in patients with type 2 diabetes: a single-blind, randomized clinical trial. Int J Food Sci Nutr. 2017 Mar;68(2):249-255. doi: 10.1080/09637486.2016.1229760. Epub 2016 Sep 16.
- Individual participant dataSharing planned: No. I haven't started working on it yet and made progress.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aylin Ayaz, Prof.Dr. study director
Hacettepe University Nutrition and Dietetics Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Nutrition Therapy (MNT) and Hardaliye (200 mL/day) in people with Fibromyalgia and Fibromyalgia (FM), run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Kahraman, Research Assistant (+90 530 642 70 86, tubasezer@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire Revised (time frame: Baseline to Week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07403929, which also lists 96 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.