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临床试验/NCT05550818
NCT05550818已完成不适用

Influence of Ultra-processed Foods on Reward Processing and Energy Intake

Virginia Polytechnic Institute and State University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Change in Brain Response From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The participants will be blind to what diet is being provided.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

High Ultra Processed Food Diet

Experimental

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

干预措施: High Ultra Processed Food Diet (Other)

No Ultra Processed Food Diet

Experimental

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

干预措施: No Ultra Processed Food Diet (Other)

结局指标

主要结局

Change in Brain Response From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet

时间窗: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)

Brain response to milkshake was measured using functional magnetic resonance imaging (fMRI). On the first level a contrast of milkshake \> tasteless was built. The measures presented here are the beta values of the milkshake\>tasteless contrast extracted from an orbital frontal cortex apriori region of interest. The pre intervention beta values were subtracted from the post intervention values. Extracted beta values are by definition arbitrary units and are the standard measure for fMRI.

次要结局

  • Energy Intake (Total Kcals Consumed) After 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurements total following the 2-week UPF diet (day 15) and following the 2-week no UPF diet (day 15))
  • Eating Rate (kcal Per Minute) After 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurements total following the 2-week UPF diet (day 15) and following the 2-week no UPF diet (day 15))
  • Number of UPF Food Items Selected After 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurement (once following the 2-week UPF diet, once following the 2-week no UPF diet))
  • Change in Grams of UPF vs no UPF Food Items Selected After 2 Weeks High UPF or 2 Weeks no UPF Diet in the ad Libitum Buffet Meal Task(2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet))
  • Change in Amount of Energy (Kcals) Selected From UPF vs no UPF Food Items After 2 Weeks High UPF or 2 Weeks no UPF Diet in the ad Libitum Buffet Meal Task(2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet))
  • Change in Grams of Food Selected From 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet))
  • Change in Energy Intake From 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15))
  • Change in Eating Rate From 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15))
  • Change in Food Items Selected From 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet))
  • Change in Amount of Energy (Kcals) Selected From 2 Weeks High UPF or 2 Weeks no UPF Diet(2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra DiFeliceantonio

Assistant Professor

Virginia Polytechnic Institute and State University

研究点 (2)

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