ObesityNCT06467604
CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users
An observational study of Obesity, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Surveys, Indirect Calorimetry and Body composition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Obesity
- Being tested
- Surveys, Indirect Calorimetry, Body composition, Anthropometrics
- Keywords
- GLP-1, diet quality, weight loss, anti-obesity medication, food cravings
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysBehavioural
Also called FCI-II, 3 day Food Diary, Hunger VAS, BED-7
Participants will be provided electronic surveys at 3 timepoints throughout study.
Indirect CalorimetryOther
Participants will receive indirect calorimetry at 3 time points throughout the study.
Body compositionOther
Also called Seca mBCA 554
Participants will receive body scans using bioelectrical impedence seca mBCA 554 digital body composition analysis scale 3 time points throughout the study.
AnthropometricsOther
Also called Waist circumference, Height, Weight
Participants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | eligible patients who are prescribed semaglutide for their obesity-management Receives: Behavioral: Surveys; Other: Indirect Calorimetry; Other: Body composition; Other: Anthropometrics | |
| Tirzepatide | eligible patients who are prescribed tirzepatide for their obesity-management Receives: Behavioral: Surveys; Other: Indirect Calorimetry; Other: Body composition; Other: Anthropometrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Food Craving Score
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."
Measured: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Secondary outcomes (1)
Change in USDA Healthy Eating Index-2015 (HEI) Score
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.
Measured: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Nov 2024
- Primary completion12 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Knownwell
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467604
- Sponsor's protocol ID
- 2184712
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babazadeh D, Therrien S, Fitch AK, Steinberg FM. Changes in food cravings, dietary quality, body composition, and dietary intake during GLP-1 receptor agonist therapy: The CRAVE study. Obes Pillars. 2026 Jun 29;19:100292. doi: 10.1016/j.obpill.2026.100292. eCollection 2026 Sep.
PubMed 42440974
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users
- ClinicalTrials.gov ID
- NCT06467604
- Acronym / sponsor ID
- 2184712
- Conditions
- Obesity
- Keywords
- GLP-1, diet quality, weight loss, anti-obesity medication, food cravings
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Knownwell
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | – | Behavioral: Surveys, Other: Indirect Calorimetry, Other: Body composition, Other: Anthropometricseligible patients who are prescribed semaglutide for their obesity-management |
| Tirzepatide | – | Behavioral: Surveys, Other: Indirect Calorimetry, Other: Body composition, Other: Anthropometricseligible patients who are prescribed tirzepatide for their obesity-management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysAlso: FCI-II, 3 day Food Diary, Hunger VAS, BED-7Participants will be provided electronic surveys at 3 timepoints throughout study. | Behavioural | Semaglutide, Tirzepatide |
| Indirect CalorimetryParticipants will receive indirect calorimetry at 3 time points throughout the study. | Other | Semaglutide, Tirzepatide |
| Body compositionAlso: Seca mBCA 554Participants will receive body scans using bioelectrical impedence seca mBCA 554 digital body composition analysis scale 3 time points throughout the study. | Other | Semaglutide, Tirzepatide |
| AnthropometricsAlso: Waist circumference, Height, WeightParticipants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study. | Other | Semaglutide, Tirzepatide |
Primary outcome
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."
1 secondary outcome
Change in USDA Healthy Eating Index-2015 (HEI) Score
Time frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42440974Babazadeh D, Therrien S, Fitch AK, Steinberg FM. Changes in food cravings, dietary quality, body composition, and dietary intake during GLP-1 receptor agonist therapy: The CRAVE study. Obes Pillars. 2026 Jun 29;19:100292. doi: 10.1016/j.obpill.2026.100292. eCollection 2026 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Food Craving Score (time frame: Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06467604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.