Regulatory Watch: Hardaliye Fermented Grape Juice in Medical Nutrition Therapy for Fibromyalgia Under Trial (NCT07403929)

Regulators and clinicians watch a new trial testing Hardaliye fermented grape juice as part of medical nutrition therapy for fibromyalgia, signaling regulatory implications for dietary interventions.

In February 2026 the ClinicalTrials.gov entry NCT07403929 lists a study sponsored by Hacettepe University that is Not yet recruiting and outlines an intervention framework that combines behavioral Medical Nutrition Therapy with an oral beverage component, Hardaliye, at a target of 200 mL per day.

In this article

• What changed in the trial and why it matters to regulators
• What is Hardaliye and how is it used in this study
• What regulatory considerations apply to this trial
• What safety and ethics considerations are noted
• FAQ
• Conclusion
• Disclaimer
• Announcement line

What changed in this fibromyalgia trial and why it matters to regulators?

The record for the fibromyalgia study shows an intervention that integrates dietary components into a medical nutrition therapy framework. Conditions listed include Fibromyalgia; Interventions show Behavioral: Medical Nutrition Therapy (MNT) and Other: Hardaliye (200 mL/day). The sponsor is Hacettepe University and the trial is not yet recruiting. The entry identifies the trial where the patient facing component is the daily dose of Hardaliye and clarifies that the intervention is described within a research protocol rather than a device function. The trial identification NCT07403929 is provided, enabling stakeholders to review the study details on ClinicalTrials.gov. This information matters for regulatory teams assessing how dietary inputs are documented, labeled and evaluated, and whether any device-like claims might be implicated should future results prompt changes in product labeling or medical guidance.

What is Hardaliye and how is it used in this study?

Hardaliye is named as the chosen beverage in the study’s intervention arm. The design specifies Hardaliye at 200 mL per day to be used alongside a medical nutrition therapy approach for fibromyalgia. The design description comes from the record as listed in the trial entry; no efficacy data are reported in the source text. The combination of a beverage component with behavioral nutrition therapy places the intervention in the realm of dietary inputs rather than a device per se, which has implications for how it is regulated and monitored in the trial context.

What regulatory considerations apply to this trial?

The trial is registered on ClinicalTrials.gov under NCT07403929 and is listed as not yet recruiting, with Hacettepe University identified as the sponsor. This setup indicates a formal research protocol subject to ethics review and regulatory oversight for clinical trials that involve a dietary intervention. Because the description centers on a nutritional beverage rather than a medical device or pharmaceutical product, the primary regulatory focus is on study conduct, informed consent, safety monitoring and accurate reporting of outcomes in the registry. Should future results suggest marketing claims or product labeling changes, the regulatory assessment would consider whether any device related claims were implied and require appropriate classification or clarification under MDR guidelines. Statements in the source text are provided as manufacturer or sponsor notes and do not constitute regulatory guidance.

What safety and ethics considerations are noted?

The source text does not provide safety results or adverse event data. As with any clinical trial, ethics committee approval and informed consent would be required in practice, and ongoing safety monitoring would typically accompany study activities. The absence of safety data in the source text means readers should watch the ClinicalTrials.gov entry for updates and ensure any dissemination aligns with standard research ethics and regulatory reporting practices.

Conclusion

This early stage trial represents a formal inquiry into a nutritional beverage as part of medical nutrition therapy for fibromyalgia. Readers should monitor the ClinicalTrials.gov entry for status updates, recruitment developments and any eventual results that could influence clinical practice or labeling considerations in a regulatory context.

Disclaimer

This article is intended for professionals and does not constitute legal advice. It summarizes regulatory considerations based on the provided source text and is not a substitute for regulatory counsel.