[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05437809":3,"trial-entities:NCT05437809":101,"trial-summary:NCT05437809":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":13,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":58,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":14,"eligibility_criteria":71,"std_ages":75,"locations":78,"central_contacts":94,"overall_officials":98,"references":99,"see_also_links":100},"NCT05437809","K23DK129825","Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods","RECRUITING","2027-03-31","2026-02","2026-02-12","2023-02-20","Oregon Research Institute","OTHER",false,"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.","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\u002For 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.\n\nIndividuals (n=50) with obesity will be recruited for the current study. Participants will attend four appointments (order randomized\u002Fcounterbalanced) 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\u002Fbehavioral 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.",[18,19,20],"Obesity","Overeating","Food Addiction",[22,23],"Ultra-processed foods","Food reward","INTERVENTIONAL",[26],"NA",{"count":28,"type":29},50,"ESTIMATED",[31],{"type":13,"name":32,"description":33,"armGroupLabels":34},"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.",[35,36,37,38],"MPF high in fat or carbohydrates","UPF high in fat","UPF high in fat and refined carbohydrates","UPF high in refined carbohydrates",[40,44,48,52,55],{"measure":41,"description":42,"timeFrame":43},"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.",{"measure":45,"description":46,"timeFrame":47},"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)",{"measure":49,"description":50,"timeFrame":51},"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.",{"measure":53,"description":54,"timeFrame":47},"Daily calorie intake (EMA)","Calorie intake will be derived from participants' self-reported food consumption in EMA surveys.",{"measure":56,"description":57,"timeFrame":47},"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.",[59,62,65],{"measure":60,"description":61,"timeFrame":43},"Changes in heart rate in response to food intake","Manually measured by counting the radial pulse for 15 seconds (timed using a digital stopwatch).",{"measure":63,"description":64,"timeFrame":43},"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.",{"measure":66,"description":67,"timeFrame":43},"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.","ALL","18 Years","65 Years",{"inclusion":72,"exclusion":73,"raw_text":74},[],[],"Inclusion Criteria Men and women Age 18-65 years BMI ≥ 30 kg\u002Fm2 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\u002Fable to participate in six in-person assessments Can access and are willing\u002Fable to use a smartphone\n\nExclusion 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\u002F90 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\u002For 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\u002For technician not being able to find a vein.",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"status":7,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":91},"Drexel University","Philadelphia","Pennsylvania","19104","United States",[86],{"name":87,"role":88,"phone":89,"email":90},"Erica M LaFata, PhD","CONTACT","9136535022","es3344@drexel.edu",{"lat":92,"lon":93},39.95238,-75.16362,[95],{"name":96,"role":88,"phone":89,"email":97},"Erica M. LaFata, Ph.D.","elafata@ori.org",[],[],[],{"nct_id":4,"conditions":102,"biomarkers":103},[18],[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an interventional study with 50 participants. It will compare how different types of ultra-processed foods affect individuals.","completed","Study on Ultra-Processed Foods and Overeating in Adults with Obesity","This study is looking at how different types of ultra-processed foods (UPFs) affect our bodies and eating habits. Researchers want to understand if UPFs high in fat, refined carbohydrates (like sugar), or both, make people want to eat more. You would attend four visits where you'd eat different snack types: UPFs high in fat and refined carbs, UPFs high in fat, UPFs high in refined carbs, or minimally processed foods. The study will measure your responses before and after eating these snacks to see how they impact your desire to eat more. This research aims to find new ways to help people who overeat and have obesity. The study is currently recruiting 50 adults, aged 18-65, who have obesity and enjoy the test snacks.","Your subjective reward responses to food intake will be measured for up to 120 minutes after eating the test snack, and through surveys for 5 days after each food consumption assessment.",124,"You would attend four food consumption assessment visits. After each visit, you would complete surveys for 5 days.","Not stated in the trial record.",[],"v2"]