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Clinical Trials in Italy / NCT06921304
Active, not recruiting Not applicable

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

NCT06921304 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Phase
Not applicable
Started
2024-01-08
Last updated
2026-04-09

Condition(s) studied

Graves Disease

Investigational drug(s) / intervention(s)

Intensive Lifestyle Intervention

Intensive Lifestyle Intervention: ILI combines a low-calorie dietary approach with improved lifestyle and physical activity, in addition to usual medical care. Behavioral support for lifestyle intervention will also be provided.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Body weight increase vs pre-disease weight — Through study completion, an average of 1 year
    Weight gain compared to the estimated pre-disease body weight. A 'failure' will be defined as a weight gain of more than 1 kg above the patient-reported estimated pre-disease body weight, assessed 12 months after the start of the study. Body weight and height will be combined to report BMI in kg/m\^2

Trial sites (1)

FacilityCityRegionStatus
Istituti Clinici Maugeri IRCCS Pavia PV

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921304 on ClinicalTrials.gov ↗ ← All trials in Italy