An interventional study of Intensive Lifestyle Intervention in Graves Disease, sponsored by Istituti Clinici Scientifici Maugeri SpA. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Prevention
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:
Participants will:
If in the ILI group, participants will:
Attend follow-up visits at 3, 6, 9, and 12 months for:
If in the UMC group, participants will:
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.
What is the BASE-DIET Study? The BASE-DIET study is a clinical trial looking at how a healthy diet and lifestyle program can help people newly diagnosed with Graves' disease (an autoimmune thyroid condition) manage weight changes and improve their health during and after treatment.
Graves' disease often causes weight loss when it's active. But after treatment, many people gain back the weight-and sometimes even more than they had before. This study wants to find out if a personalized diet and lifestyle approach can help prevent that excessive weight gain and promote better health outcomes.
Why is this study important? When thyroid function is brought back to normal (called "euthyroidism"), many patients regain weight. In fact, up to 80% of patients report weight gain after treatment, which can impact self-esteem and health.
Some research shows this weight gain might go beyond what people weighed before getting sick. This study wants to see whether a structured diet and lifestyle program can make a positive difference compared to the usual medical care alone.
Who is participating in the study?
Adults newly diagnosed with Graves' disease at endocrinology clinics in Italy are invited to take part. Participants must:
How is the study organized?
The study randomly assigns people to one of two groups:
Intervention Group (ILI) - This group receives:
Control Group (UMC) - This group receives:
Secondary goals include:
At each check-up, researchers will:
How many people are in the study? The study plans to enroll 60 people (30 in each group), which accounts for a small number of possible dropouts.
Is the study safe and ethical?
Yes. It follows strict ethical guidelines:
What will happen with the results?
Results will be:
150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 54 is close to the median of 60 across 92 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 113 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Usual Medical Care for Graves' Disease and general lifestyle advice
Usual Medical Care for Graves' Disease plus a personalized diet and lifestyle counseling
Behavioral: 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.
Body weight increase vs pre-disease weight
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
Time frame: Through study completion, an average of 1 year
BMI changes
Direct comparison of the BMI achieved at the end of the study period between the two groups, with subsequent calculation of weight gain relative to baseline weight. Weight change will be assessed as the difference between the weight measured in kilograms at the end of the study and that measured at the beginning, expressed as a percentage of the initial weight. Body weight and height will be combined to report BMI in kg/m\^2
Time frame: Through study completion, an average of 1 year
Adherence to the Mediterranean Diet
A successful outcome will be defined as an improvement in adherence scores based on the PREDIMED questionnaire.
Time frame: Through study completion, an average of 1 year
Changes in body composition parameters
This will be defined as the normalization of abnormal values of fat mass percentage, lean mass, or total body water detected at baseline (T0). For participants with optimal values at T0, success will be defined as maintaining optimal parameters; worsening of these parameters will be considered a failure.
Time frame: Through study completion, an average of 1 year
Changes in waist-to-hip ratio
A successful outcome will be defined as an improvement in waist-to-hip ratio in participants with abnormal values at baseline. For those with optimal values at T0, maintaining optimal parameters will be considered a success, while deterioration will be considered a failure.
Time frame: Through study completion, an average of 1 year
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Istituti Clinici Scientifici Maugeri SpA