Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Surveys | Participants will be provided electronic surveys at 3 timepoints throughout study. |
| OTHER | Indirect Calorimetry | Participants will receive indirect calorimetry at 3 time points throughout the study. |
| OTHER | Body composition | Participants will receive body scans using bioelectrical impedence seca mBCA 554 digital body composition analysis scale 3 time points throughout the study. |
| OTHER | Anthropometrics | Participants 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.