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

April 13, 2026 updated by: University of California, Davis
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Needham, Massachusetts, United States, 02492
        • Knownwell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study includes male and female participants aged 18 to under 70 years diagnosed with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, sleep apnea, cardiovascular disease). They must have a history of at least one unsuccessful dietary effort to lose weight and be on a stable medication regimen affecting weight or diabetes outcomes for at least three months. Short courses of antibiotics and steroids are allowed. Participants must have maintained a stable weight (±5%) over the past three months, be under physician care, provide food diary data, have a smartphone or tablet for a food logging app, communicate in English, and provide informed consent.

Description

Inclusion Criteria:

  1. Male or female, age 18.0-<70 years
  2. 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.
  3. 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)
  4. Weight stable (+/- 5%) over previous 3 months
  5. Be under the care of a physician who will be responsible for managing participant's treatment regimen
  6. Willingness to provide food diary data throughout trial
  7. Access to a smartphone/tablet that can download the food logging application
  8. Willing and able to provide a valid email address for use in the study
  9. Be able to communicate (oral and written) in English
  10. Be able to provide informed consent

Exclusion Criteria:

  1. History of weight loss surgery
  2. History of major surgery within three months of enrollment
  3. Recent weight fluctuations exceeding 5 kg within a 3-month period preceding screening
  4. Use of systemic hormonal therapies (contraceptive medication is allowed)
  5. History of Type 1 or type 2 diabetes, HgbA1c ≥ 6.5% (gestational diabetes is allowed)
  6. Hemoglobinopathy that interferes with measurement of HbA1c
  7. Treatment with any GLP-1 Receptor Agonist medication(s) within 90 days of screening
  8. Significant kidney or liver disease, malnutrition, or any condition that, in the investigator's judgment, should exclude participation
  9. Documented chronic diseases including thyroid disease, kidney disease, active cancer, previous cardiovascular events, history or presence of chronic pancreatitis, or other gastrointestinal issues
  10. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  11. Current cancer or cancer treatment, or history of cancer or cancer treatment within the last 3 years, excluding specific cases
  12. Diagnosis or strong clinical suspicion of eating disorders
  13. Background of significant active or unstable major depressive disorder (MDD) or any other severe psychiatric disorder within the past 2 years
  14. Lifetime history of a suicide attempt
  15. History of gastroparesis or other gut dysmotility syndrome
  16. Prior use of other GLP-1RA or combination GIP/GLP-1RA medications or previous participation in any GLP-1RA trials
  17. Pregnant or lactating women, women planning to become pregnant in the next 12 months
  18. Multiple patient-reported food allergies/intolerances significantly limiting food intake
  19. Smoking, illicit drug use, vaporizer and/or electronic cigarette use
  20. Currently consuming >14 alcoholic drinks per week
  21. Extreme dietary or exercise patterns
  22. Individuals who are not yet adults (infants, children, teenagers)
  23. Individuals who are currently incarcerated or serving a prison sentence
  24. Individuals unable to provide informed consent due to factors such as mental incapacity or language barriers
  25. 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:

  1. 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.
  2. If a patient develops active cancer (except skin cancer), they will be excluded from further participation due to safety concerns/contraindications for weight loss.
  3. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Semaglutide
eligible patients who are prescribed semaglutide for their obesity-management
Behavioral: Surveys
Participants will be provided electronic surveys at 3 timepoints throughout study.
Other Names:
  • FCI-II
  • 3 day Food Diary
  • Hunger VAS
  • BED-7
  • HFSS 2-item food insecurity survey
  • MESA Neighborhood Healthy Food
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 Names:
  • Seca mBCA 554
Other: Anthropometrics
Participants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study.
Other Names:
  • Weight
  • Waist circumference
  • Height
Tirzepatide
eligible patients who are prescribed tirzepatide for their obesity-management
Behavioral: Surveys
Participants will be provided electronic surveys at 3 timepoints throughout study.
Other Names:
  • FCI-II
  • 3 day Food Diary
  • Hunger VAS
  • BED-7
  • HFSS 2-item food insecurity survey
  • MESA Neighborhood Healthy Food
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 Names:
  • Seca mBCA 554
Other: Anthropometrics
Participants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study.
Other Names:
  • Weight
  • Waist circumference
  • Height

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Food Craving Score
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Effect of GLP1 medications on food cravings measured by the food-craving inventory (FCI-II) questionnaire.The FCI-II is scored on a Likert scale from 1-5, with 1 being "Never," 5 being "Always/Almost every day."
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in USDA Healthy Eating Index-2015 (HEI) Score
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Effect of GLP1 medications on Healthy Eating Index-2015. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in weight in kilograms
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Effect of GLP1 medications on weight (in kg)
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Changes in waist circumference (cm)
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Changes in resting metabolic rate (RMR)
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Effect of GLP1 medications on resting metabolic rate, assessed by indirect calorimetry.
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Change in weight loss percentage
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Changes in body fat percentage
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Measured by seca mBCA 554 bioelectrical impedance analysis
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Changes in skeletal muscle mass (lbs)
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Measured by seca mBCA 554 bioelectrical impedance analysis
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Changes in visceral fat mass (L)
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Measured by seca mBCA 554 bioelectrical impedance analysis
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Changes in segmental skeletal muscle mass (lbs)
Time Frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Measured by seca mBCA 554 bioelectrical impedance analysis
Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Knownwell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2184712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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