Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

The changing food environment, with increasingly abundant ultra-processed food (UPF) options, may directly contribute to rising rates of obesity, though it is unknown which ingredients in UPF elevate their reinforcing nature in a way that may lead to overconsumption. The proposed study is the first to systematically examine differences in the rewarding characteristics of and physiological and metabolic responses to UPFs that are high in fat, refined carbohydrates (like sugar), or both. Understanding the biobehavioral underpinnings that enhance the reinforcing potential of ingredients in UPF (e.g., fat vs. refined carbohydrates) can inform novel intervention targets for the treatment of overeating and obesity.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Food Addiction; Overeating
• Intervention / Treatment: Other: Intake of nutritionally diverse ultra-processed foods

Detailed Description

The abundance of ultra-processed foods (UPFs) in our environment has led to excessive calorie intake and been cited as perpetuating the obesity epidemic. UPFs do not exist in nature and are created to maximize palatability through the additions of fat, refined carbohydrates (RC), and/or sodium (e.g., chocolate, potato chips). Emerging research suggests UPFs may be reinforcing akin to rewarding substances like alcohol. However, empirical investigation of which ingredients in UPFs directly motivate overeating is in its nascent stages. This study will be the first to combine biological and behavioral methods used in addiction research with assessments of food reward, to delineate the mechanisms by which fat and RC drive UPF reinforcement and influence future consumption.

Individuals (n=50) with obesity will be recruited for the current study. Participants will attend four appointments (order randomized/counterbalanced) and will consume a snack consisting of 1) UPF high in fat + RC (UPF+FRC), 2) UPF high in fat (UPF+F), 3) UPF high in RC (UPF+RC), or 4) minimally processed foods (MPF). At each assessment, subjective experiences and metabolic responses will be assessed before and up to 120 minutes after consumption of each snack. An ad-libitum eating period for each food condition will follow to evaluate associations of metabolic/behavioral responses with subsequent intake. For five days after each appointment, participants will use ecological momentary assessment (EMA) to assess subjective experiences and real-world reported consumption of UPF+FRC, UPF+F, UPF+RC, and MPF.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erica M. LaFata, Ph.D.; Phone Number: 9136535022; Email: elafata@ori.org

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Drexel University
      • Contact: Erica M LaFata, PhD; Phone Number: 9136535022; Email: es3344@drexel.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria Men and women Age 18-65 years BMI ≥ 30 kg/m2 Endorse liking the foods included in the compulsory test snacks at a 6 on a scale from 1-10 No history of severe psychiatric illness; current mild to moderate severity of depression, anxiety, or binge eating disorder, determined by the behavioral evaluation and the screening measures will be included Live in the greater Springfield, Oregon area and are willing/able to participate in six in-person assessments Can access and are willing/able to use a smartphone

Exclusion Criteria Medical condition that may limit consumption of compulsory test snack foods or impact metabolic responses to food consumption Type I or II diabetes (HbA1c > 6.5 based on blood test) Uncontrolled hypertension (blood pressure ≥ 140/90 mm Hg) Cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months Individuals with dietary allergies of aversions to the test snack foods Individuals taking medications that may influence the metabolic responses of interest (e.g., metformin) Individuals who are actively pursuing weight loss or have lost ≥ 5% of their initial weight in the last 6 months Severe symptoms of mood, anxiety, and any severity of thought disorders Severe binge eating disorder or full criteria bulimia Persons with active substance-use disorders Current, active suicidal ideation, and/or a suicide attempt within the past year History of bariatric surgery Women who are nursing, pregnant, or planning to become pregnant in the next three months Self-report current diagnosis of a transferrable blood condition (including HIV, hepatitis B, hepatitis C, or syphilis) Self-report prior history of being dizzy or anxious during blood draws and/or technician not being able to find a vein.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: UPF high in fat and refined carbohydrates; This test snack condition consists of ultra-processed foods high in both fat and refined carbohydrates.	Other: Intake of nutritionally diverse ultra-processed foods; All participants will attend four food consumption assessment visits where, at each visit, they will be asked to consume a standardized snack portion of: 1) ultra-processed foods (UPFs) high in both fat and refined carbohydrates (UPF+FRC), 2) UPF high in fat (UPF+F), 3) UPF high in refined carbohydrates (white flour, sugar) (UPF+RC), or 4) minimally processed foods. The order of the four food consumption assessment visits will be randomized and counterbalanced across participants, who will each consume all the test snacks across the four appointments.
Other: UPF high in fat; This test snack condition consists of ultra-processed foods high in fat.	Other: Intake of nutritionally diverse ultra-processed foods; All participants will attend four food consumption assessment visits where, at each visit, they will be asked to consume a standardized snack portion of: 1) ultra-processed foods (UPFs) high in both fat and refined carbohydrates (UPF+FRC), 2) UPF high in fat (UPF+F), 3) UPF high in refined carbohydrates (white flour, sugar) (UPF+RC), or 4) minimally processed foods. The order of the four food consumption assessment visits will be randomized and counterbalanced across participants, who will each consume all the test snacks across the four appointments.
Other: UPF high in refined carbohydrates; This test snack condition consists of ultra-processed foods high in refined carbohydrates.	Other: Intake of nutritionally diverse ultra-processed foods; All participants will attend four food consumption assessment visits where, at each visit, they will be asked to consume a standardized snack portion of: 1) ultra-processed foods (UPFs) high in both fat and refined carbohydrates (UPF+FRC), 2) UPF high in fat (UPF+F), 3) UPF high in refined carbohydrates (white flour, sugar) (UPF+RC), or 4) minimally processed foods. The order of the four food consumption assessment visits will be randomized and counterbalanced across participants, who will each consume all the test snacks across the four appointments.
Other: MPF high in fat or carbohydrates; This test snack condition consists of minimally processed foods naturally high in either fat or carbohydrates.	Other: Intake of nutritionally diverse ultra-processed foods; All participants will attend four food consumption assessment visits where, at each visit, they will be asked to consume a standardized snack portion of: 1) ultra-processed foods (UPFs) high in both fat and refined carbohydrates (UPF+FRC), 2) UPF high in fat (UPF+F), 3) UPF high in refined carbohydrates (white flour, sugar) (UPF+RC), or 4) minimally processed foods. The order of the four food consumption assessment visits will be randomized and counterbalanced across participants, who will each consume all the test snacks across the four appointments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective reward responses to food intake (in lab)	Indicators of subjective reward (craving, palatability, hedonic hunger, and mood) will be assessed by participants' self-reports before, during, and after consumption of the test snack at each of the four food consumption appointments. Each facet of subjective reward will be assessed by 100-point visual analog scales ranging from 0-100.	10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.
Subjective reward responses to food intake (EMA)	Indicators of subjective reward (craving, palatability, hedonic hunger, and mood) will be assessed by participants' self-reports in EMA surveys. Each facet of subjective reward will be assessed by 100-point visual analog scales ranging from 0-100.	EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)
Ad libitum consumption	Total number of calories consumed from the test snack food during a 15-minute eating period. Calories will calculated by measuring bowls containing the test snacks before and after participant consumption on a digital scale accurate to 0.01 grams. The difference in grams will be converted into the calories that the participant ate.	2 hours after test snack intake at each food consumption assessment.
Daily calorie intake (EMA)	Calorie intake will be derived from participants' self-reported food consumption in EMA surveys.	EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)
Consumption of UPFs and MPFs (EMA)	Trained study staff will calculate the percentage of participants' daily calories from the four food categories (UPF+FRC, UPF+F, UPF+RC, MPF) based on participants' self-reported food consumption in EMA surveys.	EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in heart rate in response to food intake	Manually measured by counting the radial pulse for 15 seconds (timed using a digital stopwatch).	10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.
Salivation responses to food intake	Participants will spit into a plastic cup for 1 minute and the weight of their saliva will be measured in grams using a digital food scale accurate to 0.01 grams.	10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.
Magnitude of metabolic responses to food intake	Serial blood draws will be conducted before, during, and after test snack consumption. Samples will be assayed for glucose, insulin, ghrelin, and leptin levels.	10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual risk factors for enhanced ultra-processed food reward	Characteristics known to increase one's reward responsiveness to substances like alcohol will be assessed by behavioral tasks and evaluated as predictors of ultra-processed food reward (delay discounting task to assess impulsivity; Stroop task to assess cognitive functioning; relative reinforcing value task to assess reward value of various foods).	Tasks administered at baseline assessment (prior to any food consumption appointments) or follow-up assessment (at least one week or up to 2 months after the last food consumption appointment)

Collaborators and Investigators

• Sponsor: Oregon Research Institute
• Collaborators: Oregon Research Institute Community and Evaluation Services

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: June 19, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ultra-processed foods; Food reward
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Signs and Symptoms, Digestive; Overweight; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Food Addiction; Obesity; Hyperphagia
• Other Study ID Numbers: K23DK129825 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The project will generate multi-modal data from 50 adults with obesity, including repeated measures of subjective reward responses, physiological and metabolic markers (e.g., heart rate, insulin, glucose, ghrelin, leptin), ecological momentary assessment (EMA) reports, and behavioral task performance (e.g., Stroop, delay discounting, relative reinforcing value). Data will include numeric, categorical, and time-series variables collected across six study visits and four EMA sampling periods. All data will be de-identified and stored in structured formats suitable for statistical analysis.
• IPD Sharing Time Frame: Data associated with a study publication will be made available upon first publication of the findings. Data will be available indefinitely.

IPD Sharing Access Criteria

Dr. LaFata (PI) will be responsible for overseeing the data management and sharing of this project. Dr. LaFata will administer data collection, storage, and repository training to the research coordinator and to any volunteer study staff, who must demonstrate competence in all tasks before commencing their responsibilities. All project staff who use data will have received training in responsible data practices.

ORI- Community and Evaluation Services will be conducting routine monitoring inspection of randomly selected studies that have indicated a Data and Sharing Management Plan and have received or been awarded funds through NIH and subject to the NIH Data Sharing Policy.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No