- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428187
Snacking Effects on the Brain Response to Foods and Satiety During Dieting
March 19, 2026 updated by: University of Colorado, Denver
This study plans to learn more about how different types of snacks may affect brain processes relating to eating behaviors during a diet intervention.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
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
- Name: Allison Hild, BS
- Phone Number: 3037249024
- Email: allison.hild@cuanschutz.edu
Study Contact Backup
- Name: Kristina T Legget, PhD
- Phone Number: 303-724-5809
- Email: kristina.legget@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Anschutz Medical Campus
-
Contact:
- Kristina Legget, PhD
- Phone Number: 303-724-5809
- Email: kristina.legget@cuanschutz.edu
-
Contact:
- Allison Hild, BS
- Phone Number: 303-724-9024
- Email: allison.hild@cuanschutz.edu
-
Principal Investigator:
- Kristina T Legget, PhD
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 25-45 years old
- BMI at least 27 kg/m2
- Comfortable completing a weight-loss intervention\
- Willing to consume a daily snack of either walnuts or pretzels
Exclusion Criteria:
- Nut or wheat allergy
- History of bariatric surgery
- Current eating disorder
- Current illicit substance use
- Current pregnancy, lactation (or less than 3 months after stopping lactation), or less than 6 months postpartum
- Uncontrolled hypertension (>160/100 mmHg)
- Significant endocrine/metabolic disease kidney disease, liver disease, or blood disease that would be anticipated to affect study results
- Taking injectable medications, sulfonylureas, or meglitinides for diabetes treatment
- Taking weight-loss medications, or steroids within ~3 months prior to study participation (e.g., GLP-1 receptor agonists)
- Significant mental health changes within ~3 months prior to study participation (e.g., medication adjustments, new psychiatric diagnoses, hospitalization relating to mental health concerns)
- Neurological illnesses or injury that would be anticipated to affect MRI data
- Weight change greater than 10% within 3 months prior to study participation
- Currently participating in another weight-loss study
- Not comfortable eating the study-provided meals (with allowances for dietary preferences) and/or following a highly restrictive diet (e.g., vegan)
- MRI-specific exclusion criteria (e.g., metal in the body, weight >500 lbs
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Snack Type 1: Walnuts
Participants will complete a 12 week diet intervention, during which they will be asked to reduce their daily caloric intake.
During the diet intervention, participants in the Snack Type 1 group will be asked to eat a daily snack of walnuts, which will be provided by the study team.
Participants will meet with study staff on a weekly basis during the intervention (with some meetings virtual and in-person visits every 2-3 weeks).
|
Participants will complete a 12 week diet intervention, during which they will be asked to reduce their daily caloric intake.
During the diet intervention, participants in the Snack Type 1 group will be asked to eat a daily snack of walnuts, which will be provided by the study team.
|
|
Active Comparator: Snack Type 2: Pretzels
Participants will complete a 12 week diet intervention, during which they will be asked to reduce their daily caloric intake.
During the diet intervention, participants in the Snack Type 2 group will be asked to eat a daily snack of pretzels, which will be provided by the study team.
Participants will meet with study staff on a weekly basis during the intervention (with some meetings virtual and in-person visits every 2-3 weeks).
|
Participants will complete a 12 week diet intervention, during which they will be asked to reduce their daily caloric intake.
During the diet intervention, participants in the Snack Type 2 group will be asked to eat a daily snack of pretzels, which will be provided by the study team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent change in Blood Oxygen Level Dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging
Time Frame: Baseline, 12 weeks
|
Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI), focusing on insula, striatum, amygdala, and prefrontal cortex.
|
Baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in percent body fat
Time Frame: Baseline, 12 weeks
|
Change in percent body fat from baseline to after the 12-week intervention.
|
Baseline, 12 weeks
|
|
Change in appetite response to a meal
Time Frame: Baseline, 12 weeks
|
Change in appetite response to a meal (area under the curve for visual analog scale [VAS] ratings of hunger and satiety across fasted and fed states) from baseline to after the 12-week intervention.
|
Baseline, 12 weeks
|
|
Change in food cravings
Time Frame: Baseline, 12 weeks
|
Change in food cravings (using the Food Cravings Questionnaire) from baseline to after the 12-week intervention
|
Baseline, 12 weeks
|
|
Change in dietary restraint
Time Frame: Baseline, 12 weeks
|
Change in dietary restraint (measured using the dietary restraint subscale of the Three Factor Eating Questionnaire) from baseline to after the 12-week intervention.
|
Baseline, 12 weeks
|
|
Change in reward-based eating drive
Time Frame: Baseline, 12 weeks
|
Change in reward based eating drive (measured using the Reward-Based Eating Drive-13 questionnaire) from baseline to after the 12-week intervention.
|
Baseline, 12 weeks
|
|
Change in waist circumference
Time Frame: Baseline, 12 weeks
|
Change in waist circumference (cm) from baseline to after the 12-week intervention
|
Baseline, 12 weeks
|
|
Change in body weight
Time Frame: Baseline, 12 weeks
|
Change in body weight (kg) from baseline to after the 12-week intervention
|
Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristina T Legget, PhD, University of Colorado, Denver
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)
March 5, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Study Registration Dates
First Submitted
February 12, 2026
First Submitted That Met QC Criteria
February 19, 2026
First Posted (Actual)
February 23, 2026
Study Record Updates
Last Update Posted (Actual)
March 23, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-1900
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.