CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users (NCT06467604) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users
United States7 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female, age 18.0-\<70 years
✓. Obese (BMI greater than or equal to 30.0 kg/m2) or overweight (BMI greater than or equal to 27.0 kg/m2) with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease and history of at least one self-reported unsuccessful dietary effort to lose body weight will be recruited.
✓. On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
✓. Weight stable (+/- 5%) over previous 3 months
✓. Be under the care of a physician who will be responsible for managing participant's treatment regimen
✓. Willingness to provide food diary data throughout trial
✓. Access to a smartphone/tablet that can download the food logging application
✓. Willing and able to provide a valid email address for use in the study
Exclusion criteria
✕. History of weight loss surgery
✕. History of major surgery within three months of enrollment
✕. Recent weight fluctuations exceeding 5 kg within a 3-month period preceding screening
What they're measuring
1
Change in Food Craving Score
Timeframe: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)