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Идёт набор NCT07229170

Changes in Taste and Eating Habits Associated With GLP-1 Agonists in Weight Loss Patients

— Наблюдательное Obesity & Overweight Taste Alterations Weight Loss Eating Behavior Changes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Obesity & Overweight, Taste Alterations, Weight Loss, Eating Behavior Changes. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Changes in Taste Perception, Eating Habits, and Other Behavioral Aspects Associated With the Use of GLP-1 Receptor Agonists in Patients Undergoing Weight Loss Treatment: A Retrospective Observational Study.

Обзор

This observational retrospective study aims to evaluate changes in taste perception, eating habits, and behavioral aspects in adults treated with GLP-1 receptor agonists for weight loss. Participants include adults aged 18-60 receiving treatment at specialized nutrition centers in Italy. Data are collected from clinical records, dietary questionnaires, and metabolic assessments before and after at least 12 weeks of GLP-1 agonist treatment. The study's primary goal is to understand how these treatments affect food preferences and taste perception. Secondary outcomes include changes in body weight, body composition, gastrointestinal side effects, and treatment adherence. All data are anonymized and collected according to ethical guidelines.

Подробное описание

This retrospective observational study investigates changes in taste perception, eating habits, and other behavioral aspects associated with the use of GLP-1 receptor agonists in patients undergoing treatment for weight loss. The study includes adults aged 18-60 years who have been treated at specialized nutrition centers in Italy during 2025-2026. Data are collected retrospectively from clinical records, dietary questionnaires, bioimpedance analysis for body composition, and metabolic assessments conducted before and after at least 12 weeks of treatment with GLP-1 agonists such as semaglutide or tirzepatide.

The primary objective is to evaluate the impact of GLP-1 agonist treatment on food preferences and taste perception changes. Secondary objectives include quantifying changes in body weight, body mass index (BMI), and body composition (fat mass and lean mass), assessing gastrointestinal side effects, measuring total energy expenditure and physical activity variations, and estimating treatment adherence and discontinuation reasons.

Data collection involves anonymized extraction of demographic, anthropometric, clinical, dietary, and behavioral information in accordance with GDPR and ethical guidelines. The analysis is performed using statistical methods including paired t-tests, Wilcoxon tests, and regression models adjusted for age, sex, baseline BMI, diabetes status, and concomitant medications.

This study is non-profit and does not involve additional costs or interventions beyond routine clinical care. Ethical approval is pending and will be obtained before the study initiation. All procedures will comply with local regulations and ethical guidelines.

Первичные конечные точки

  • Change in taste perception and food preferences [Срок оценки: From baseline to 12 weeks after GLP-1 agonist treatment]
Вторичные конечные точки (3)
  • Change in body weight [Срок оценки: From baseline to 12 weeks after treatment]
  • Gastrointestinal side effects [Срок оценки: Throughout the treatment period]
  • Treatment adherence [Срок оценки: Throughout the study duration]

Критерии участия

Inclusion: Adults aged 18-60 years diagnosed with obesity and undergoing treatment with GLP-1 receptor agonists such as semaglutide or tirzepatide. Must have clinical records and dietary data available for at least 12 weeks of treatment.

Exclusion: Patients with conditions affecting taste independent of GLP-1 treatment, severe comorbidities, or inability to provide consent and data.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 4 центра
  • San Raffaele Open University — Roma
  • Department for the Promotion of Human Science and Quality of Life San Raffaele Open Univer — Rome
  • San Raffaele Open University — Rome
  • San Raffaele Open University — Rome

Публикации

  • Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10. PMID 33567185

Идентификаторы

NCT: NCT07229170 · GLP1-TASTE

Первоисточники (государственные реестры)

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