Feeding Behavior Clinical Trial
Official title:
Specificity of Flavor-Nutrient Learning: An fMRI Experiment
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.
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.
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