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Young Adult Eating Habits

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 25 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05550818
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Virginia Polytechnic Institute and State University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alexandra G DiFeliceantonio, PhDBrenda M Davy, PhD, RDN
Principal Investigator Affiliation Virginia Polytechnic Institute and State UniversityVirginia Polytechnic Institute and State University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eating Behavior, Eating Habit
Additional Details

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.

Arms & Interventions

Arms

Experimental: High Ultra Processed Food Diet

Participants will consume a diet containing 81% total energy from UPF for 2 weeks.

Experimental: No Ultra Processed Food Diet

Participants will consume a diet containing 0% total energy from UPF for 2 weeks.

Interventions

Other: - High Ultra Processed Food Diet

Participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.

Other: - No Ultra Processed Food Diet

Participants will be provided and consume a diet containing no UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Blacksburg, Virginia

Status

Recruiting

Address

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061

Site Contact

Brenda M Davy, PhD, RDN

[email protected]

540-231-6784

Roanoke, Virginia

Status

Recruiting

Address

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016

Site Contact

Alexandra G DiFeliceantonio, PhD

[email protected]

540-526-2285

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