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Active Not RecruitingNCT06467604

CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
7 (actual)
Sponsor
University of California, Davis · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

This study aims to assess the impact of GLP-1 receptor agonists, semaglutide and tirzepatide, on food cravings and diet quality in individuals with overweight or obesity. Over 24 weeks, up to 150 adult participants will be monitored using questionnaires and dietary records at 0, 12, and 24 weeks to measure changes in diet quality, disordered eating, food cravings, and hunger. This research, conducted with Seen Medical Group at Knownwell Health Clinic, seeks to fill the gap in literature on the dietary quality effects of GLP-1RAs.

Detailed description

This study aims to evaluate the impact of GLP-1 receptor agonist (GLP-1RA) medications, specifically semaglutide and tirzepatide, on food cravings and diet quality among individuals diagnosed with overweight and obesity. Participants will be recruited through Knownwell Health clinical staff, who will refer eligible patients to the UCD research team for further information and screening. At Knownwell Clinic, standard care for patients on GLP-1RA medications includes blood draws, blood pressure evaluations, body composition analysis (Seca), and indirect calorimetry testing. These procedures will be conducted at baseline (week 0), midpoint (weeks 8-12), and end of titration/max dose (week 24). Participants will complete a series of virtual questionnaires on nutrition, eating habits, and diet quality, along with a 3-day food diary. Regular medical appointments will follow Knownwell Clinic's standards of care. Participants must procure their own GLP-1RA medication. This study adds questionnaires to assess: dietary quality (photo-based food records), hunger (hunger VAS survey) and food cravings (FCI-II) related to GLP-1RA use.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSurveysParticipants will be provided electronic surveys at 3 timepoints throughout study.
OTHERIndirect CalorimetryParticipants will receive indirect calorimetry at 3 time points throughout the study.
OTHERBody compositionParticipants will receive body scans using bioelectrical impedence seca mBCA 554 digital body composition analysis scale 3 time points throughout the study.
OTHERAnthropometricsParticipants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study.

Timeline

Start date
2024-11-01
Primary completion
2027-03-12
Completion
2027-04-01
First posted
2024-06-21
Last updated
2026-04-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06467604. Inclusion in this directory is not an endorsement.