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Recruiting NCT07428187

Snacking Effects on the Brain Response to Foods and Satiety During Dieting

No phase Interventional Overweight/Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Snack Type 1: Walnuts, Snack Type 2: Pretzels.
Who it may be relevant to
Registry conditions: Overweight/Obesity. Basic parameters: 25 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Change in percent body fat [Time frame: Baseline, 12 weeks]
  • Change in appetite response to a meal [Time frame: Baseline, 12 weeks]
  • Change in food cravings [Time frame: Baseline, 12 weeks]
  • Change in dietary restraint [Time frame: Baseline, 12 weeks]
  • Change in reward-based eating drive [Time frame: Baseline, 12 weeks]
  • Change in waist circumference [Time frame: Baseline, 12 weeks]
  • Change in body weight [Time frame: Baseline, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT07428187 · 25-1900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗