BASE-DIET: a Study on Nutritional Intervention in Patients With Graves' Disease

Launched by ISTITUTI CLINICI SCIENTIFICI MAUGERI SPA · Apr 8, 2025

Keywords

ClinConnect Summary

The BASE-DIET clinical trial is investigating whether a special diet can help people with Graves' disease maintain a healthy weight and improve their overall health after starting treatment. Graves' disease affects the thyroid, which can lead to symptoms like weight loss and increased metabolism. In this study, some participants will receive a personalized Mediterranean-style diet and lifestyle coaching, while others will get standard medical care with general lifestyle advice. The researchers want to find out if those on the special diet regain less weight and see better improvements in their body composition and eating habits.

To join the trial, participants must be adults diagnosed with Graves' disease within the past month and meet certain health criteria. They will receive treatment for their condition and be randomly assigned to one of two groups: one will follow the personalized diet plan, and the other will continue with standard care. Throughout the study, participants will attend regular check-ups to track their progress and how well they stick to the diet. This trial aims to provide valuable information about how nutrition can support people dealing with Graves' disease and help manage their weight and health risks.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Diagnosis of Graves' disease in an endocrinology setting based on the presence of thyrotoxicosis and positive TRAb antibodies.
• • Diagnosis of Graves' disease within 1 month prior to randomization.
• • BMI \> 16 kg/m² and \< 35 kg/m² at the time of the first visit for Graves' disease.
• • Age \> 18 years.
• • Ability to commit to the duration of the study.
• • Ability to provide informed consent and willingness to participate in the study.
• • Exclusion Criteria
• • Relapse of Graves' disease or thyrotoxicosis not related to Graves' disease.
• • Any serious cardiovascular or renal event in the last 6 months.
• • Current pregnancy, breastfeeding, or planning pregnancy during the study period.
• • Any condition potentially leading to fluid overload such as heart failure (NYHA class \> I) or liver cirrhosis.
• • Previously diagnosed significant psychiatric disorder (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder).
• • Active eating disorder.
• • Uncontrolled depression.
• • Uncontrolled epilepsy.
• • Known cause of malabsorption (including uncontrolled celiac disease, lactose intolerance, or inflammatory bowel disease).
• • Ongoing therapy with weight-modifying medications (e.g., GLP-1 analogs, metformin).
• • Estimated BMI before disease onset \< 18 kg/m². This parameter will be calculated based on the "estimated pre-disease body weight" as reported by the patient.