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Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

Primary Purpose

Obesity, Overeating, Food Addiction

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intake of nutritionally diverse ultra-processed foods

About this trial

This is an interventional other trial for Obesity focused on measuring Ultra-processed foods, Food reward

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 to 65 years old
BMI ≥ 30 kg/m2
Endorse liking the test snack foods at a 6 on a 1-10 scale
Live in the greater Philadelphia area and are willing/able to participate in six in-person assessments
Can access and are willing/able to use a smartphone
Able to give consent

Exclusion Criteria:

Unable to fluently speak, write, and read English
BMI below 30 kg/m2
Self-report dietary allergies or aversions to the test snack foods
Current diagnosis of type 1 or 2 diabetes (HbA1c > 6.5; will be confirmed by blood test at baseline) or self-reported diagnosis of hypertension
Self-report a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months
Self-report current use of medications that may influence the metabolic responses of interest or inhibit appetite (e.g., metformin, liraglutide)
Self-report a loss of ≥ 5% of their body weight in the last 6 months, as this may influence their food choices
Self-report severe symptoms of mood (Beck Depression Inventory score ≥ 29), anxiety, and any severity of thought disorders
Self-report severe binge eating disorder or full criteria bulimia nervosa
Self-report active substance-use disorders
Self-report current, active suicidal ideation, and/or a suicide attempt in the past year (will be referred to psychiatric treatment facilities in the greater Philadelphia area)
Self-report a history of bariatric surgery
Self-report current involvement in weight loss treatment or self-directed weight loss attempt
Women who are nursing, pregnant, or planning to become pregnant in the next 3 months
Does not have access or are not willing to use a smartphone

Sites / Locations

Drexel UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adults with obesity

Arm Description

All participants (n=50 adults with obesity) will complete each of the four food consumption appointments (order of the four appointments will be randomized/counterbalanced).

Outcomes

Primary Outcome Measures

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.

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.

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.

Daily calorie intake (EMA)

Calorie intake will be derived from participants' self-reported food consumption in EMA surveys.

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.

Secondary Outcome Measures

Changes in heart rate in response to food intake

Manually measured by counting the radial pulse for 15 seconds (timed using a digital stopwatch).

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.

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.

Full Information

NCT ID

NCT05437809

First Posted

June 19, 2022

Last Updated

February 14, 2023

Sponsor

Drexel University

1. Study Identification

Unique Protocol Identification Number

NCT05437809

Brief Title

Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

Official Title

Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 27, 2023 (Actual)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overeating, Food Addiction

Keywords

Ultra-processed foods, Food reward

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adults with obesity

Arm Type

Other

Arm Description

All participants (n=50 adults with obesity) will complete each of the four food consumption appointments (order of the four appointments will be randomized/counterbalanced).

Intervention Type

Other

Intervention Name(s)

Intake of nutritionally diverse ultra-processed foods

Intervention Description

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 Information:

Title

Subjective reward responses to food intake (in lab)

Description

Time Frame

10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.

Title

Subjective reward responses to food intake (EMA)

Description

Time Frame

EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)

Title

Ad libitum consumption

Description

Time Frame

2 hours after test snack intake at each food consumption assessment.

Title

Daily calorie intake (EMA)

Description

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)

Title

Consumption of UPFs and MPFs (EMA)

Description

Time Frame

EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)

Secondary Outcome Measure Information:

Title

Changes in heart rate in response to food intake

Description

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.

Title

Salivation responses to food intake

Description

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.

Title

Magnitude of metabolic responses to food intake

Description

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 Pre-specified Outcome Measures:

Title

Individual risk factors for enhanced ultra-processed food reward

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 to 65 years old BMI ≥ 30 kg/m2 Endorse liking the test snack foods at a 6 on a 1-10 scale Live in the greater Philadelphia area and are willing/able to participate in six in-person assessments Can access and are willing/able to use a smartphone Able to give consent Exclusion Criteria: Unable to fluently speak, write, and read English BMI below 30 kg/m2 Self-report dietary allergies or aversions to the test snack foods Current diagnosis of type 1 or 2 diabetes (HbA1c > 6.5; will be confirmed by blood test at baseline) or self-reported diagnosis of hypertension Self-report a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months Self-report current use of medications that may influence the metabolic responses of interest or inhibit appetite (e.g., metformin, liraglutide) Self-report a loss of ≥ 5% of their body weight in the last 6 months, as this may influence their food choices Self-report severe symptoms of mood (Beck Depression Inventory score ≥ 29), anxiety, and any severity of thought disorders Self-report severe binge eating disorder or full criteria bulimia nervosa Self-report active substance-use disorders Self-report current, active suicidal ideation, and/or a suicide attempt in the past year (will be referred to psychiatric treatment facilities in the greater Philadelphia area) Self-report a history of bariatric surgery Self-report current involvement in weight loss treatment or self-directed weight loss attempt Women who are nursing, pregnant, or planning to become pregnant in the next 3 months Does not have access or are not willing to use a smartphone

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erica M. LaFata, Ph.D.

Phone

9136535022

es3344@drexel.edu

Facility Information:

Facility Name

Drexel University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erica M LaFata, PhD

Phone

913-653-5022

es3344@drexel.edu

12. IPD Sharing Statement

Plan to Share IPD

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Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

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