NCT07428187

Brief Summary

This study plans to learn more about how different types of snacks may affect brain processes relating to eating behaviors during a diet intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

February 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

February 12, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

DietingWeight lossOverweightObesityFoodNeuroimagingBody weightEatingBrainMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Percent change in Blood Oxygen Level Dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging

    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 Outcomes (7)

  • Change in percent body fat

    Baseline, 12 weeks

  • Change in appetite response to a meal

    Baseline, 12 weeks

  • Change in food cravings

    Baseline, 12 weeks

  • Change in dietary restraint

    Baseline, 12 weeks

  • Change in reward-based eating drive

    Baseline, 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Snack Type 1: Walnuts

EXPERIMENTAL

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).

Other: Snack Type 1: Walnuts

Snack Type 2: Pretzels

ACTIVE COMPARATOR

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).

Other: Snack Type 2: Pretzels

Interventions

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.

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 2 group will be asked to eat a daily snack of pretzels, which will be provided by the study team.

Snack Type 2: Pretzels

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesityWeight LossBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Kristina T Legget, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 23, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations