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NCT06921304: BASEDIET
BASE-DIET: a Study on Nutritional Intervention in Patients With Graves' Disease
NA trial testing Intensive Lifestyle Intervention in Graves Disease in 54 participants. Participants enrolled and being followed up; not accepting new ones.
30 September 2026
Quick facts
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 54 |
| Start date | 8 January 2024 |
| Primary completion | 30 September 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Intensive Lifestyle Intervention
Conditions studied
- Graves Disease — all drugs for Graves Disease →
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Who can join
18 and older, any sex, with Graves Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to determine whether a structured dietary-nutritional intervention can prevent excessive weight regain and improve body composition and lifestyle habits in adults recently diagnosed with Graves' disease (Basedow's disease). The main questions it aims to answer are: * Can a dietary intervention prevent patients from regaining more than 1 kg above their pre-disease body weight after restoring euthyroidism? * Does the intervention lead to improvements in body composition, dietary habits, and adherence to the Mediterranean diet? Researchers will compare patients receiving an Intensive Lifestyle Intervention (ILI) including a personalized diet and lifestyle counseling to patients receiving Usual Medical Care (UMC) with general lifestyle advice to see if the dietary intervention results in less weight regain and better metabolic and anthropometric outcomes. Participants will: * Receive antithyroid medication as standard medical care. * Be randomized into either the intervention group (ILI) or control group (UMC). If in the ILI group, participants will: * Receive an individual nutritional consultation within 1 week of enrollment. * Follow a personalized Mediterranean-style low-energy diet. * Attend follow-up visits at 3, 6, 9, and 12 months for: * Dietary adherence and lifestyle assessments. * Anthropometric measurements (weight, BMI, waist/hip circumference). * Bioimpedance analysis (at 6 and 12 months) for body composition. * Dietary intake logs and adherence assessments (3-day food diary). If in the UMC group, participants will: * Receive routine clinical management for Graves' disease. * Complete basic dietary and lifestyle questionnaires at baseline and 12 months. * Undergo anthropometric measurements and bioimpedance at T0 and at the end of study. This study aims to provide evidence on the role of nutritional support in managing weight and metabolic risks in patients undergoing treatment for Graves' disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06921304
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Graves Disease
Currently open trials in the same condition.
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- NCT07129642 — Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease · EARLY_PHASE1 · recruiting
- NCT07369063 — Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease · Phase 2 · recruiting
Other Istituti Clinici Scientifici Maugeri SpA trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06921304 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituti Clinici Scientifici Maugeri SpA
- Last refreshed: 9 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06921304.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing