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

NCT06921304 | Active Not Recruiting

• 1 other identifier: BASE-DIET 01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Graves Disease

Keywords

graves disease; diet; body weight; PREDIMED

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• BMI changes

  Through study completion, an average of 1 year

• Adherence to the Mediterranean Diet

  Through study completion, an average of 1 year

• Changes in body composition parameters

  Through study completion, an average of 1 year

• Changes in waist-to-hip ratio

  Through study completion, an average of 1 year

Study Arms (2)

Usual Medical Care (UMC)

NO INTERVENTION

Usual Medical Care for Graves' Disease and general lifestyle advice

Intensive Lifestyle Intervention (ILI)

EXPERIMENTAL

Usual Medical Care for Graves' Disease plus a personalized diet and lifestyle counseling

Behavioral: Intensive Lifestyle Intervention

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

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.

Intensive Lifestyle Intervention (ILI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Maugeri IRCCS

Pavia, PV, 27100, Italy

Location

Related Publications (9)

• Croce L, Pallavicini C, Busca N, Cali B, Bellastella G, Coperchini F, Magri F, Chiovato L, Cena H, Rotondi M. Pre-surgery dietician counseling can prevent post-thyroidectomy body weight gain: results of an intervention trial. Endocrine. 2023 Aug;81(2):246-251. doi: 10.1007/s12020-023-03365-z. Epub 2023 Apr 19.

  PMID: 37074559 BACKGROUND

• Pijl H, de Meijer PH, Langius J, Coenegracht CI, van den Berk AH, Chandie Shaw PK, Boom H, Schoemaker RC, Cohen AF, Burggraaf J, Meinders AE. Food choice in hyperthyroidism: potential influence of the autonomic nervous system and brain serotonin precursor availability. J Clin Endocrinol Metab. 2001 Dec;86(12):5848-53. doi: 10.1210/jcem.86.12.8112.

  PMID: 11739450 BACKGROUND

• van Veenendaal NR, Rivkees SA. Treatment of pediatric Graves' disease is associated with excessive weight gain. J Clin Endocrinol Metab. 2011 Oct;96(10):3257-63. doi: 10.1210/jc.2011-1601. Epub 2011 Aug 17.

  PMID: 21849528 BACKGROUND

• Chng CL, Lim AY, Tan HC, Kovalik JP, Tham KW, Bee YM, Lim W, Acharyya S, Lai OF, Chong MF, Yen PM. Physiological and Metabolic Changes During the Transition from Hyperthyroidism to Euthyroidism in Graves' Disease. Thyroid. 2016 Oct;26(10):1422-1430. doi: 10.1089/thy.2015.0602. Epub 2016 Sep 7.

  PMID: 27465032 BACKGROUND

• Kim MJ, Cho SW, Choi S, Ju DL, Park DJ, Park YJ. Changes in Body Compositions and Basal Metabolic Rates during Treatment of Graves' Disease. Int J Endocrinol. 2018 May 3;2018:9863050. doi: 10.1155/2018/9863050. eCollection 2018.

  PMID: 29853888 BACKGROUND

• Krassas GE, Pontikides N, Loustis K, Koliakos G, Constantinidis T, Panidis D. Resistin levels in hyperthyroid patients before and after restoration of thyroid function: relationship with body weight and body composition. Eur J Endocrinol. 2005 Aug;153(2):217-21. doi: 10.1530/eje.1.01963.

  PMID: 16061827 BACKGROUND

• Hoogwerf BJ, Nuttall FQ. Long-term weight regulation in treated hyperthyroid and hypothyroid subjects. Am J Med. 1984 Jun;76(6):963-70. doi: 10.1016/0002-9343(84)90842-8.

  PMID: 6731468 BACKGROUND

• Alton S, O'Malley BP. Dietary intake in thyrotoxicosis before and after adequate carbimazole therapy; the impact of dietary advice. Clin Endocrinol (Oxf). 1985 Nov;23(5):517-20. doi: 10.1111/j.1365-2265.1985.tb01111.x.

  PMID: 4085132 BACKGROUND

• Lonn L, Stenlof K, Ottosson M, Lindroos AK, Nystrom E, Sjostrom L. Body weight and body composition changes after treatment of hyperthyroidism. J Clin Endocrinol Metab. 1998 Dec;83(12):4269-73. doi: 10.1210/jcem.83.12.5338.

  PMID: 9851762 BACKGROUND

MeSH Terms

Conditions

Graves Disease; Body Weight

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 10, 2025
• Study Start: January 8, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)