Clinical trial NCT02624206: Specificity of Flavor-Nutrient Learning: An fMRI Experiment
Official title: Specificity of Flavor-Nutrient Learning: An fMRI Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Inhibition (Psychology)
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-12-08
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Study design and Participants The investigators randomly assigned participants to consume one of two novel flavored, high-sugar beverages daily for a 3-week period. The study included fMRI and behavioral assessments pre-/post-intervention and 9 study visits during the intervention period. 20, healthy-weight, young adults (10 female, 10 male; x̅ age = 23.3±3.4; x̅ BMI = 22.1±1.9; 5% Hispanic,10% Asian/Pacific Islanders, 85% European Americans) completed protocol seen in Figure 1a. Exclusion criteria were a body mass index (BMI; kg/m2) \<18.5 or \>26.5, sweetened (artificial or caloric) beverage consumption \> 6 times/week, tobacco/e-cigarette use \> 6 times/week, psychoactive medications or drugs more than \> 1 time/month, pregnancy, head injury with a loss of consciousness, significant cognitive impairment, major medical problems, endorsement of disordered eating or current Axis I psychiatric disorder as assessed by online screener. Participants provided written informed consent; methods and procedures were approved by University of North Carolina at Chapel Hill's Institutional Review Board.

Intervention Interested participants completed a brief online screening survey those that appeared to qualify were scheduled for the baseline visit where inclusion and exclusion were confirmed and consent was reviewed and obtained. Participants were randomly assigned to one of the two juice conditions, stratified by sex. Once consented, participants completed the behavioral and perceptual measures at the baseline behavioral assessment. On a separate day participants completed the baseline neuroimaging assessment. The day following the neuroimaging assessment participants began the intervention period where they consumed their assigned juice daily for the 3-week period. During the intervention period participants came to our lab every Monday, Wednesday and Friday (9 total assessments) to: consume a portion of that day's juice in the lab, complete perceptual measures and a weight assessment, pick up the following day(s) juice, and return the empty bottles from the previous day(s). On Fridays, participants were given two bottles to consume and instructed to consume one per day and return the bottles on the following Monday. Empty bottles were returned to increase compliance. The follow-up neuroimaging assessment was scheduled such that participants completed the 3-week intervention, did not consume a juice for 24 hours and then were scanned. The follow-up behavioral assessment occurred within three days of the follow-up scan Figure 1b.

Beverages were selected to be: sweetened from sugar, i.e., not include high fructose corn syrup, and/or artificial sweeteners, have no artificial flavors, colors or preservatives, calorically equivalent to common sugar-sweetened beverages (e.g., soft drinks), be caffeine- and texture-free, and generally novel in flavor. The juices were eucaloric, had similar palatability, and easily distinguishable from one another. Prior to study initiation, pilot taste testing was completed in a small sample to insure both the novelty and equal palatability of the two juices to be included in the study. The resulting two beverages were: Apple-Cherry-Berry juice and Orange-Tangerine-Passionfruit juice. The 10 fl oz bottles of juice each contained 133 kcals, 31g of sugar. The juice logos were selected to be novel, of similar visual complexity, both in black and white, convey no information beyond a unique symbol, yet be easily distinguishable from one another. Each juice was presented in individual 10 fl oz bottles with the only identifier a sticker of the associated logo.

Eligibility criteria: Inclusion Criteria:

* BMIs between 19 and 25

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
Secondary outcomes:
measure: Change in Response Time to Logo as Measured in Behavioral Impulsivity Task
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
measure: Change in Error Rate to Logo as Measured in Behavioral Impulsivity Task
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
measure: Change score in Visual Analog Scale Ratings of Beverage Perceptual Measures
timeFrame: Baseline, Intervention Visits 1-9 (over 3 weeks), Post-Intervention Assessment (about 3 weeks after baseline)
measure: Change in Restrained Eating Subscale Score as measured on Dutch Eating Behavior Questionnaire.
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
measure: Changes in Food Pattern From Baseline to Post-Intervention Assessment by Food Frequency Questionnaire.
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
measure: Change in Food Craving as assessed by the Food Craving Inventory (FCI) Score Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
measure: Change in Hedonic Hunger as assessed by the Power of Food Scale (PFS) Score
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
measure: Change in Food Habits as assessed by the Yale Food Addiction Scale
timeFrame: Baseline, Post-Intervention Assessment (about 3 weeks after baseline)
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kyle Burger, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.