ObesityNCT05437809
Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods
A study testing Intake of nutritionally diverse ultra-processed foods in people with Obesity and Overeating, run by Oregon Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overeating, Food Addiction
- What is being tested?
- Intake of nutritionally diverse ultra-processed foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Overeating, Food Addiction
- Being tested
- Intake of nutritionally diverse ultra-processed foods
- Keywords
- Ultra-processed foods, Food reward
- Medical subject headings
- Obesity, Hyperphagia, Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of nutritionally diverse ultra-processed foodsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| UPF high in fat and refined carbohydrates | Other | This test snack condition consists of ultra-processed foods high in both fat and refined carbohydrates. Receives: Other: Intake of nutritionally diverse ultra-processed foods |
| UPF high in fat | Other | This test snack condition consists of ultra-processed foods high in fat. Receives: Other: Intake of nutritionally diverse ultra-processed foods |
| UPF high in refined carbohydrates | Other | This test snack condition consists of ultra-processed foods high in refined carbohydrates. Receives: Other: Intake of nutritionally diverse ultra-processed foods |
| MPF high in fat or carbohydrates | Other | This test snack condition consists of minimally processed foods naturally high in either fat or carbohydrates. Receives: Other: Intake of nutritionally diverse ultra-processed foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Manually measured by counting the radial pulse for 15 seconds (timed using a digital stopwatch).
Measured: 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.
Measured: 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.
Measured: 10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start20 Feb 2023
- Primary completion7 Jul 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Research Institute Community and Evaluation Services
- Responsible party
- Principal investigator, elafata@ori.org, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437809
- Sponsor's protocol ID
- K23DK129825
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods
- ClinicalTrials.gov ID
- NCT05437809
- Acronym / sponsor ID
- K23DK129825
- Conditions
- Obesity, Overeating, Food Addiction
- Keywords
- Ultra-processed foods, Food reward
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- Oregon Research Institute Community and Evaluation Services
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UPF high in fat and refined carbohydrates | Other | Other: Intake of nutritionally diverse ultra-processed foodsThis test snack condition consists of ultra-processed foods high in both fat and refined carbohydrates. |
| UPF high in fat | Other | Other: Intake of nutritionally diverse ultra-processed foodsThis test snack condition consists of ultra-processed foods high in fat. |
| UPF high in refined carbohydrates | Other | Other: Intake of nutritionally diverse ultra-processed foodsThis test snack condition consists of ultra-processed foods high in refined carbohydrates. |
| MPF high in fat or carbohydrates | Other | Other: Intake of nutritionally diverse ultra-processed foodsThis test snack condition consists of minimally processed foods naturally high in either fat or carbohydrates. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intake of nutritionally diverse ultra-processed foodsAll 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, UPF high in fat, UPF high in fat and refined carbohydrates, UPF high in refined carbohydrates |
Primary outcome
Subjective reward responses to food intake (in lab)
Time frame: 10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.
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.
Subjective reward responses to food intake (EMA)
Time frame: EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)
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.
Ad libitum consumption
Time frame: 2 hours after test snack intake at each food consumption assessment.
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.
Daily calorie intake (EMA)
Time frame: EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)
Calorie intake will be derived from participants' self-reported food consumption in EMA surveys.
Consumption of UPFs and MPFs (EMA)
Time frame: EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)
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.
3 secondary outcomes
Changes in heart rate in response to food intake
Time frame: 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
Time frame: 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
Time frame: 10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intake of nutritionally diverse ultra-processed foods in people with Obesity and Overeating, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective reward responses to food intake (in lab) (time frame: 10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.