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

NCT03490734 | Completed Results

• 2 other identifiers: 17-07101R01DK112317-01A1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity; Weight Gain

Keywords

nutrition; obesity; weight gain; sugar; sugar sweetened beverage; dopamine; neurobehavioral adaptation

Outcome Measures

Primary Outcomes (1)

• 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

  The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages (sweet and unsweet) and a water solution, and logo-elicited anticipation of both beverages and water solution. The visual stimuli are two beverage logos, a water logo, and a fixation cross. Each logo (1 second) signals impending delivery of 3 mL of the associated juice/water over 6 seconds, with the fixation cross otherwise presented. A jitter ranging from 5 to 13 seconds follows each trial. In total, the participants are shown 24 repeats of the events of interest over 4, 7-minute runs. Contrasts of interest are the post- \> pre-intervention BOLD response to sweetened beverage logo \> water logo. Parameter estimates for these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in whole-brain BOLD response for sweetened beverage logo \> water logo for each arm.

  Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment

Secondary Outcomes (3)

• Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI)

  Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment

• Beverage Perceptual Ratings Using Visual Analog Scales

  Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment

• Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task

  Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment

Other Outcomes (12)

• Percent Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in During Rest

  Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment

• Modulation of Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo by TaqIA Single Nucleotide Polymorphism Status

  Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment

• Change in Food Pattern From Baseline to Post-Intervention Assessment by Food Frequency Questionnaire

  Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment

Study Arms (4)

Beverage A (Sweetened)

ACTIVE COMPARATOR

One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

Dietary Supplement: Black Cherry and Orange Flavored Beverage with added sugar; Other: Water

Beverage B (Sweetened)

ACTIVE COMPARATOR

One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

Dietary Supplement: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar; Other: Water

Beverage A (Unsweetened)

ACTIVE COMPARATOR

One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

Dietary Supplement: Black Cherry and Orange Flavored Beverage no added sugar; Other: Water

Beverage B (Unsweetened)

ACTIVE COMPARATOR

One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

Dietary Supplement: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar; Other: Water

Interventions

Black Cherry and Orange Flavored Beverage with added sugar DIETARY_SUPPLEMENT

10 oz daily for three weeks

Also known as: Kool-Aid®

Beverage A (Sweetened)

Strawberry Kiwi &Lemonade Flavored Beverage with added sugar DIETARY_SUPPLEMENT

10 oz daily for three weeks

Also known as: Kool-Aid®

Beverage B (Sweetened)

Black Cherry and Orange Flavored Beverage no added sugar DIETARY_SUPPLEMENT

10 oz daily for three weeks

Also known as: Kool-Aid®

Beverage A (Unsweetened)

Strawberry Kiwi & Lemonade Flavored Beverage no added sugar DIETARY_SUPPLEMENT

10 oz daily for three weeks

Also known as: Kool-Aid®

Beverage B (Unsweetened)

Water OTHER

Three mL administered per associated logo presentation only during MRI procedure.

Beverage A (Sweetened); Beverage A (Unsweetened); Beverage B (Sweetened); Beverage B (Unsweetened)

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mcgavran-Greenberg Hall

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

• Peirce JW. PsychoPy--Psychophysics software in Python. J Neurosci Methods. 2007 May 15;162(1-2):8-13. doi: 10.1016/j.jneumeth.2006.11.017. Epub 2007 Jan 23.

  PMID: 17254636 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Gain

Interventions

Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Kyle Burger, PhD, RD, MPH
• Organization: University of North Carolina at Chapel Hill

kyle_burger@unc.edu

9198439933

Study Officials

• Kyle Burger, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Experimental and flavor conditions will be blinded to those performing analyses.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stratified randomization techniques will be used to distribute: 1) male \& females, 2) those with a BMI \> 26.1 \& those with a BMI \< 26.1, and 3) regular SSB consumers (\> 1/day; 12 fl oz) \& low or non-SSB consumers equally across the 2 experimental conditions (SSB vs. unsweetened beverage) and then to the two flavors within each experimental condition. BMI of 26.0 was selected as it is the midpoint of inclusion criteria 18 \< BMI \< 34.

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 6, 2018
• Study Start: April 10, 2018
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: April 6, 2023
• Results First Posted: April 6, 2023

Record last verified: 2022-08

Locations

US (1)