Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOregon Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Intake of nutritionally diverse ultra-processed foods
Other interventionAll 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.
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: UPF high in fat and refined carbohydratesOther 1 intervention
Group B: UPF high in fatOther 1 intervention
Group C: UPF high in refined carbohydratesOther 1 intervention
Group D: MPF high in fat or carbohydratesOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.2
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.
Time frame
EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)3
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.
Time frame
2 hours after test snack intake at each food consumption assessment.4
Daily calorie intake (EMA)
Calorie intake will be derived from participants' self-reported food consumption in EMA surveys.
Time frame
EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)Secondary outcomes
1
Changes in heart rate in response to food intake
Manually measured by counting the radial pulse for 15 seconds (timed using a digital stopwatch).
Time frame
10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.2
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.
Time frame
10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.3
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.
Time frame
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
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).
Time frame
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)Sponsors and contacts
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Oregon Research Institute
Lead sponsor
Oregon Research Institute Community and Evaluation Services
Collaborator
Source ClinicalTrials.gov