- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229170
Changes in Taste and Eating Habits Associated With GLP-1 Agonists in Weight Loss Patients (GLP1-TASTE)
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mauro Lombardo, MD
- Phone Number: +393899740197
- Email: mauro.lombardo@uniroma5.it
Study Locations
-
-
-
Rome, Italy, 00166
- Recruiting
- Department for the Promotion of Human Science and Quality of Life San Raffaele Open University
-
Contact:
- Alessandra Feraco, PhD
- Phone Number: +39 339 869 8874
- Email: alessandra.feraco@uniorma5.it
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Rome, Italy, 00166
- Active, not recruiting
- San Raffaele Open University
-
Rome, Italy, 00166
- Recruiting
- San Raffaele Open University
-
Contact:
- Mauro Lombado
- Phone Number: +393899740197
-
-
Italy
-
Roma, Italy, Italy, 00166
- Recruiting
- San Raffaele Open University
-
Contact:
- Stefania Supino, PhD
- Phone Number: +39 800 128 606
- Email: stefania.supino@uniroma5.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
GLP-1 Agonist Treated Patients
This cohort includes adult patients aged 18-60 who have been treated with GLP-1 receptor agonists such as semaglutide or tirzepatide for weight loss in specialized nutrition centers in Italy.
The study collects retrospective data on changes in taste perception, eating habits, body composition, and treatment adherence over a minimum duration of 12 weeks of therapy.
No interventional treatments are administered as part of this observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in taste perception and food preferences
Time Frame: From baseline to 12 weeks after GLP-1 agonist treatment
|
Assessment of patients' taste perception changes and shifts in eating habits using validated questionnaires and behavioral surveys.
|
From baseline to 12 weeks after GLP-1 agonist treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body weight
Time Frame: From baseline to 12 weeks after treatment
|
Measured in kilograms to assess weight loss effectiveness.
|
From baseline to 12 weeks after treatment
|
|
Gastrointestinal side effects
Time Frame: Throughout the treatment period
|
Recording of nausea, vomiting, diarrhea, or other GI symptoms via patient reports.
|
Throughout the treatment period
|
|
Treatment adherence
Time Frame: Throughout the study duration
|
Assessment of continued use and discontinuation reasons of GLP-1 agonists.
|
Throughout the study duration
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLP1-TASTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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