Recruiting

Nutritionally Diverse Foods

Sponsor:

Oregon Research Institute

Code:

NCT05437809

Conditions

Obesity

Overeating

Food Addiction

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Intake of nutritionally diverse ultra-processed foods

Study Details

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.

Conditions

Obesity

Overeating

Food Addiction

Study ID

NCT05437809

Start date

Feb 20, 2023

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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: UPF high in fat

This test snack condition consists of ultra-processed foods high in fat.

other: UPF high in refined carbohydrates

This test snack condition consists of ultra-processed foods high in refined carbohydrates.

other: MPF high in fat or carbohydrates

This test snack condition consists of minimally processed foods naturally high in either fat or carbohydrates.

Interventions

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.

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. ]
  • 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) ]
  • Ad libitum consumption [ Time Frame: 2 hours after test snack intake at each food consumption assessment. ]
  • Daily calorie intake (EMA) [ Time Frame: EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Erica M. LaFata, Ph.D.

9136535022elafata@ori.org

Locations

Drexel University

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erica M LaFata, PhD

9136535022es3344@drexel.edu

More Information

Sponsor

Oregon Research Institute

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Ultra-processed foods
  • Food reward

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Oregon Research Institute on 2026-02-12.