Specificity of Flavor-Nutrient Learning: An fMRI Experiment

NCT02624206 | Completed

• 2 other identifiers: 14-1669P30DK056350
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an etiology study designed to examine the how people's brains and behaviors respond to regularly consuming a beverage. Participants are assessed at 2 behavioral assessments (Wave 1 and Wave 2), 2 scans (at the BRIC), and at 9 'intervention' assessments (5-10mins) different time periods throughout the study. At their first assessment (W1) they are randomized into one of two juices.

Conditions

Feeding Behavior; Inhibition (Psychology)

Outcome Measures

Primary Outcomes (1)

• Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo: Percent Change in BOLD Activations Including Outliers

  The juice fMRI paradigm assessed evoked blood oxygen level dependent (BOLD) response to receipt of both juices and a tasteless solution, and logo-elicited anticipation of both juices and tasteless solution. The paradigm was controlled by in-house scripts written in MATLAB (Mathworks, Inc., Natick, MA). The visual stimuli were two juice logos, a tasteless logo, and a fixation cross. Each logo (4 seconds) signaled impending delivery of 0.5 mL of the associated juice/tasteless over 4 seconds, with the fixation cross otherwise presented. Participants were visually instructed on when to swallow. A jitter ranging from 5 to 13 (x̅ =8) seconds followed each trial. In total, the participants were presented 27 repeats of the events of interest over 3, 12 min runs.

  Baseline, Post-Intervention Assessment (about 3 weeks after baseline)

Secondary Outcomes (8)

• Change in Response Time to Logo as Measured in Behavioral Impulsivity Task

  Baseline, Post-Intervention Assessment (about 3 weeks after baseline)

• Change in Error Rate to Logo as Measured in Behavioral Impulsivity Task

  Baseline, Post-Intervention Assessment (about 3 weeks after baseline)

• Change score in Visual Analog Scale Ratings of Beverage Perceptual Measures

  Baseline, Intervention Visits 1-9 (over 3 weeks), Post-Intervention Assessment (about 3 weeks after baseline)

• Change in Restrained Eating Subscale Score as measured on Dutch Eating Behavior Questionnaire.

  Baseline, Post-Intervention Assessment (about 3 weeks after baseline)

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

  Baseline, Post-Intervention Assessment (about 3 weeks after baseline)

Study Arms (2)

Juice A

ACTIVE COMPARATOR

Half of the group to receive Juice A, a novel juice flavor.

Dietary Supplement: Juice A

Juice B

ACTIVE COMPARATOR

Half of the group to receive Juice B, a novel juice flavor different from Juice A.

Dietary Supplement: Juice B

Interventions

Juice A DIETARY_SUPPLEMENT

Subjects to be given juice daily for 3 weeks.

Juice A

Juice B DIETARY_SUPPLEMENT

Subjects to be given juice daily for 3 weeks.

Juice B

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMIs between 19 and 25

You may not qualify if:

• Contraindicators of fMRI (e.g., metal implants, braces, or pregnancy)
• Symptoms of major psychiatric disorders (substance use disorders, conduct disorder, ADHD, major depression, bipolar disorder, anorexia nervosa, bulimia nervosa, binge eating disorder)
• Active weight loss dieting
• Use of psychoactive drugs (e.g., cocaine)
• Serious medical problems (e.g., diabetes)
• Smoking
• Dietary practices that do not allow intake of dairy products during the phone screen will be excluded

Sponsors & Collaborators

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

Related Publications (1)

• Burger KS. Frontostriatal and behavioral adaptations to daily sugar-sweetened beverage intake: a randomized controlled trial. Am J Clin Nutr. 2017 Mar;105(3):555-563. doi: 10.3945/ajcn.116.140145. Epub 2017 Feb 8.

  PMID: 28179221 DERIVED

MeSH Terms

Conditions

Feeding Behavior; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Kyle Burger, PhD, MPH, RD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: December 8, 2015
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 1, 2017

Record last verified: 2015-11