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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467604
• Other study ID #: 2184712-2
• Status: Recruiting
• Start date: June 12, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: University of California, Davis
• Contact: Francene M Steinberg, PhD, RD
• Phone: ?(530) 752-0160?
• Email: fmsteinberg[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: September 12, 2025
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• Body composition
Participants will receive body scans using bioelectrical impedence seca mBCA 554 digital body composition analysis scale 3 time points throughout the study.
• Anthropometrics
Participants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study.

Locations

Country	Name	City	State
United States	Knownwell	Needham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Knownwell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in weight in kilograms	Effect of GLP1 medications on weight (in kg)	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other	Changes in waist circumference (cm)		Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other	Changes in resting metabolic rate (RMR)	Effect of GLP1 medications on resting metabolic rate, assessed by indirect calorimetry.	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other	Change in weight loss percentage		Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other	Changes in body fat percentage	Measured by seca mBCA 554 bioelectrical impedance analysis	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other	Changes in skeletal muscle mass (lbs)	Measured by seca mBCA 554 bioelectrical impedance analysis	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other	Changes in visceral fat mass (L)	Measured by seca mBCA 554 bioelectrical impedance analysis	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Other	Changes in segmental skeletal muscle mass (lbs)	Measured by seca mBCA 554 bioelectrical impedance analysis	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Primary	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."	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)
Secondary	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.	Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)