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N/A N=160 Randomized Single-blind Diagnostic

Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment

Obesity · Weight Gain

Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo — -2.69; -3.06 arbitrary units — p=0.52

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Black Cherry and Orange Flavored Beverage with added sugar (Dietary_supplement); Strawberry Kiwi &Lemonade Flavored Beverage with added sugar (Dietary_supplement); Black Cherry and Orange Flavored Beverage no added sugar (Dietary_supplement); Strawberry Kiwi & Lemonade Flavored Beverage no added sugar (Dietary_supplement); Water (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo
-2.69; -3.06 0.52
SECONDARY
Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI)
3.47; -9.82 0.016 sig
SECONDARY
Beverage Perceptual Ratings Using Visual Analog Scales
25.00; -21.00; 24.20; -8.84; 20.30; -23.70
SECONDARY
Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task
0.5321; 0.5452; 0.5013; 0.5360

Summary

The proposed project will examine the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB).

Eligibility Criteria

Inclusion Criteria

  • Potential participants will be eligible for the study if they have BMI scores between the 18 and 34 at baseline.

Exclusion Criteria

  • Individuals with probable current Axis I psychopathology or any fMRI contra-indicators (e.g., metal implants, braces) will be excluded. Those with a probable Axis I diagnosis will be provided with treatment referral information and encouraged to seek treatment,
  • current regular use (3 or more times a week) of psychoactive drugs (e.g., cocaine, marijuana, nicotine),
  • regular smoking,
  • serious medical problems (e.g., cancer, diabetes),
  • dietary practices that do not allow intake of intervention beverages.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03490734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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