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

University of California (UC) Davis

Status

Active, not recruiting

Conditions

Obesity

Treatments

Behavioral: Surveys

Other: Anthropometrics

Other: Indirect Calorimetry

Other: Body composition

Study type

Observational

Funder types

Other

Identifiers

NCT06467604

2184712

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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
Be able to communicate (oral and written) in English
Be able to provide informed consent

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
Use of systemic hormonal therapies (contraceptive medication is allowed)
History of Type 1 or type 2 diabetes, HgbA1c ≥ 6.5% (gestational diabetes is allowed)
Hemoglobinopathy that interferes with measurement of HbA1c
Treatment with any GLP-1 Receptor Agonist medication(s) within 90 days of screening
Significant kidney or liver disease, malnutrition, or any condition that, in the investigator's judgment, should exclude participation
Documented chronic diseases including thyroid disease, kidney disease, active cancer, previous cardiovascular events, history or presence of chronic pancreatitis, or other gastrointestinal issues
Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
Current cancer or cancer treatment, or history of cancer or cancer treatment within the last 3 years, excluding specific cases
Diagnosis or strong clinical suspicion of eating disorders
Background of significant active or unstable major depressive disorder (MDD) or any other severe psychiatric disorder within the past 2 years
Lifetime history of a suicide attempt
History of gastroparesis or other gut dysmotility syndrome
Prior use of other GLP-1RA or combination GIP/GLP-1RA medications or previous participation in any GLP-1RA trials
Pregnant or lactating women, women planning to become pregnant in the next 12 months
Multiple patient-reported food allergies/intolerances significantly limiting food intake
Smoking, illicit drug use, vaporizer and/or electronic cigarette use
Currently consuming >14 alcoholic drinks per week
Extreme dietary or exercise patterns
Individuals who are not yet adults (infants, children, teenagers)
Individuals who are currently incarcerated or serving a prison sentence
Individuals unable to provide informed consent due to factors such as mental incapacity or language barriers
Any disorder, inability, or unwillingness to comply with the study protocol that may jeopardize patient safety or compliance, based on the investigator's opinion

Pregnancy and Other Exclusions during Trial:

If a patient experiences a pregnancy, her data will be censored from the time of estimated conception, and she will be excluded from further participation.
If a patient develops active cancer (except skin cancer), they will be excluded from further participation due to safety concerns/contraindications for weight loss.
If a patient develops another exclusionary condition, such as unstable angina or another condition for which weight loss or exercise might be contraindicated, further participation will be determined by the Medical Monitoring Team (PI, Project Manager).