Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05550818
Study type Interventional
Source Virginia Polytechnic Institute and State University
Contact Brenda M Davy, PhD, RDN
Phone 540-231-6784
Email davy@vt.edu
Status Recruiting
Phase N/A
Start date March 10, 2023
Completion date July 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT03117374 - Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy N/A
Completed NCT04025099 - Internal Cues Versus External Cues for Eating and Activity N/A
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT05485168 - Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT03850990 - Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss N/A
Completed NCT02470949 - Influence of a Monopoly Game on Subtle Behaviors N/A
Recruiting NCT01863212 - The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects N/A
Completed NCT02729675 - Innovative Approaches to Increase F&V Intake Thru Worksites Phase 2
Completed NCT05405244 - Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM Phase 3
Completed NCT04971811 - Effects of Energy Density on Self-served Snacks in Preschool Children N/A
Completed NCT05019872 - Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture N/A
Completed NCT04605224 - Effectiveness of a Culinary Class on Food Literacy and Eating Behaviours of Francophone High School Students
Recruiting NCT04526743 - Eating Behavior and Weight Trajectory After Bariatric Surgery
Active, not recruiting NCT05026411 - Food Reward Circuit Change by Orthodontics N/A
Completed NCT05173311 - Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance N/A
Completed NCT05149066 - #KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents N/A
Completed NCT03779321 - Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects N/A
Recruiting NCT06108128 - Food for Thought: Executive Functioning Around Eating Among Children N/A
Completed NCT05085041 - Healthy Online Parental Education Project to Increase Fruit and Vegetable Intake and Active Playtime Among Toddlers N/A