Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2023
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
February 12, 2026
February 1, 2026
3.9 years
June 19, 2022
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
Changes in heart rate in response to food intake
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
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
10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.
Other Outcomes (1)
Individual risk factors for enhanced ultra-processed food reward
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)
Study Arms (4)
UPF high in fat and refined carbohydrates
OTHERThis test snack condition consists of ultra-processed foods high in both fat and refined carbohydrates.
UPF high in fat
OTHERThis test snack condition consists of ultra-processed foods high in fat.
UPF high in refined carbohydrates
OTHERThis test snack condition consists of ultra-processed foods high in refined carbohydrates.
MPF high in fat or carbohydrates
OTHERThis test snack condition consists of minimally processed foods naturally high in either fat or carbohydrates.
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drexel University
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
June 19, 2022
First Posted
June 29, 2022
Study Start
February 20, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data associated with a study publication will be made available upon first publication of the findings. Data will be available indefinitely.
- 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.
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.