Clinical trial NCT05550818: Young Adult Eating Habits
Official title: Influence of Ultra-processed Foods on Reward Processing and Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Eating Habit
Keywords: Ultra-processed food
Minimally-processed food
Executive Functioning
Eating Habits
Reward Sensitivity
Brain Activity
fMRI
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Most individuals with obesity become so before age 35 and adolescent's unhealthy dietary patterns, specifically high intake of ultra-processed foods and poor overall diet quality, may contribute to energy overconsumption and weight gain. The overall objective of this research is to establish proof-of-concept for altered reward processing measured by brain response to ultra-processed foods, an increase in ad libitum energy intake, and adverse effects on executive function in response to an ultra-processed diet (81% total energy) compared to a diet emphasizing minimally processed foods in individuals aged 18-25 years.

Detailed description: Most individuals with obesity become so before age 35. In the US population, adolescents have the highest ultra- processed food consumption (68% of total energy) and the lowest diet quality. Given that ultra-processed foods represent two-thirds of the energy consumed by adolescents and young adults, research is needed to understand the influence of food processing on eating behaviors, particularly in the late adolescence and early adulthood life stage. During this time, individuals have increasing independence in food choice and it represents a key developmental period for executive function, processes that affect life-long mental and physical health. Evidence from pre-clinical studies demonstrates rodents maintained on a "cafeteria diet" comprised of ultra- processed ingredients have greater energy intake, weight gain, and alterations in brain circuitry that regulates both energy intake and executive function than those exposed to a standard diet. However, the impact of ultra- processed foods on the brain circuits underlying reward processing, food intake regulation, food choice, and executive function in humans is unknown. Controlled diet interventions are needed to fill this void. The overall objective of this research is to establish proof-of-concept for altered reward processing measured by brain response to an ultra-processed milkshake, an increase in ad libitum energy intake in a buffet meal, and adverse effects on executive function in response to a diet high in ultra-processed foods (81% total energy) compared to a diet emphasizing un/minimally-processed foods in individuals aged 18-25 years. To address our objective, 32 individuals aged 18-25 years (late adolescence/early adulthood) (BMI\<30) will undergo two 14-day controlled feeding conditions in a randomly assigned order. Diets will match the caloric needs of the individual and be matched for potential confounding factors including macronutrients, fiber, and energy density. To assess changes in reward processing, brain response to an ultra-processed milkshake will be assessed via functional magnetic resonance imaging before and after each feeding period (4 measurements). Measurements immediately following each feeding period will include ad libitum energy intake and food selection at a breakfast buffet meal (containing both ultra-processed and minimally processed foods), eating in the absence of hunger post-meal, and executive function. Although consumption of ultra-processed foods may contribute to dysregulation of energy intake, mechanisms are uncertain and existing dietary guidelines do not address ultra- processed food intake due to a lack of human experimental research. The proposed research could address this gap and inform dietary guidelines for individuals at a critical developmental life stage - late adolescence to early adulthood.

Eligibility criteria: Inclusion Criteria:

* Age 18-25 years
* Weight stable (+5 lbs) for previous 6 months
* No plans to gain/lose weight or change physical activity level
* Willing to pick up food daily and consume foods provided for two 14-day periods
* Verbal and written informed consent
* Unrestrained eater (TFEQ cognitive restraint score \<11)
* No reported history of eating disorders
* Sedentary to recreationally active
* ADHD medications if same med \>3 months at time of study

Exclusion Criteria:

* BMI \>30 kg/m2
* Endocrine disorders or other major chronic disease (e.g., type 2 diabetes, hypothyroidism, hypertension)
* Pregnant or plans to become pregnant
* Food allergies or aversions
* Claustrophobia
* History of head injury with loss of consciousness for more than 10 minutes
* Contraindications to MRI: individuals with pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

Primary outcomes:
measure: Change in brain response from baseline to 2-weeks post high UPF or 2 weeks no UPF diet
timeFrame: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)
Secondary outcomes:
measure: Change in energy intake from 2 weeks high UPF or 2 weeks no UPF diet
timeFrame: 2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15)
measure: Change in eating rate from 2 weeks high UPF or 2 weeks no UPF diet
timeFrame: 2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15)
measure: Change in food items selected from 2 weeks high UPF or 2 weeks no UPF diet
timeFrame: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)
measure: Change in grams of food selected from 2 weeks high UPF or 2 weeks no UPF diet
timeFrame: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)
measure: Change in amount of energy (kcals) selected from 2 weeks high UPF or 2 weeks no UPF diet
timeFrame: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)
Other outcomes:
measure: Change in executive function from baseline to 2-weeks post high UPF or 2 weeks no UPF diet
timeFrame: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)
measure: Change in eating in the absence of hunger from baseline to 2-weeks post high UPF or 2 weeks no UPF diet
timeFrame: 4 measurements (in person and take home portion following the 2-week UPF diet, in person and take home portion following the 2-week no UPF diet)
measure: Change in internal state ratings from 2 weeks high UPF or 2 weeks no UPF diet
timeFrame: 2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)
measure: Change in sensitivity to delayed consequences from 2 weeks high UPF or 2 weeks no UPF diet
timeFrame: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)
Locations:
city: Blacksburg
country: United States
facility: Virginia Polytechnic Institute and State University
state: Virginia
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Alexandra G DiFeliceantonio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Polytechnic Institute and State University
name: Brenda M Davy, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References: