Dietary Changes for Food Addiction

Overseen By Ashley Gearhardt, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Insulin, Antipsychotics

Disqualifiers: Diabetes, Severe mental illness, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether reducing ultra-processed (UP) foods causes withdrawal symptoms and affects adherence to a healthier diet. Participants will either reduce their UP food intake or maintain their usual diet to assess the impact on cravings and diet adherence. Ideal participants have experienced food addiction symptoms, own a smartphone, and are willing to attend lab visits and follow dietary instructions. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of UP foods on diet adherence.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes participants on medications like insulin or antipsychotics that might affect the study results or safety. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eating fewer ultra-processed (UP) foods can safely improve health. This trial does not involve a new drug; instead, it focuses on dietary changes. Eating less UP food is linked to better health, as studies have found that consuming large amounts of these foods can increase the risk of obesity and heart problems. However, reducing these foods does not add new risks and may actually lower them.

Participants in this trial will follow a diet low in UP foods. This approach is not expected to cause harm and might lead to benefits like better weight control and lower blood sugar levels. Some individuals might experience mild and temporary symptoms, such as cravings or mood changes, when reducing UP foods.

Overall, this dietary change is well-tolerated. No evidence suggests harmful effects from eating fewer UP foods. It offers a safe way to explore how diet affects health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about dietary changes for food addiction because these approaches explore the impact of ultra-processed foods on addictive eating behaviors. Unlike traditional methods that might focus on behavioral therapy or medication, these diets aim to directly address the type of food consumed. The Self-Guided Low Ultra-Processed (UP) Food Diet empowers participants to make informed choices with nutritional guidance, while the Meals Provided Low UP Food Diet ensures adherence by supplying meals. This focus on reducing ultra-processed foods could offer a new, practical method for managing food addiction that emphasizes dietary composition rather than calorie count or sheer willpower.

What evidence suggests that reducing ultra-processed food intake could be effective for food addiction?

This trial will compare different dietary approaches to reducing ultra-processed (UP) food intake. Research has shown that eating fewer UP foods can lead to better health. Studies have linked high UP food consumption to issues like heart disease and mental health problems. For instance, people who consume more UP foods often face a higher risk of these health issues. Some research also found that when people switched to eating fewer UP foods, they naturally ate less overall. This suggests that cutting down on UP foods could improve diet quality and support better health. Participants in this trial will either follow a self-guided low UP food diet, receive meals provided by the study team that are low in UP foods, or continue eating as they usually do. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 25-60 who believe they have a food addiction, consume multiple ultra-processed foods daily, and live close to the lab. They must be willing to follow dietary instructions and like chocolate milkshakes (for fMRI). Exclusions include diabetes, severe mental illness history, recent pregnancy or breastfeeding, high caffeine/alcohol intake, certain medical conditions and treatments affecting metabolism or reward functioning.

Inclusion Criteria

Must own an Android or iPhone Smartphone

Live within a 1-hour radius of the laboratory

You regularly consume a variety of unhealthy processed foods.

Exclusion Criteria

I am color blind to red and green.

You have a body mass index (BMI) that is too low (below 18.5) or too high (above 40).

You have a history of food allergies or follow a specific diet like being vegan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants complete in-lab visit #1 with questionnaires, behavioral tasks, and body composition measurements, followed by a week of remote data tasks while eating their typical diet.

1 week

1 in-person visit, 7 days of remote tasks

Dietary Intervention

Participants are randomly assigned to a control or low UP diet condition and complete in-lab visit #2, followed by a week of remote data tasks adhering to their assigned diet.

1 week

1 in-person visit, 7 days of remote tasks

Post-Intervention Assessment

Participants complete in-lab visit #3 with questionnaires, behavioral tasks, body composition measurements, and an fMRI scan.

1 day

1 in-person visit

Follow-up

Participants are contacted 1- and 3-months later to complete a short follow-up survey and provide information about their current diet.

3 months

2 virtual follow-up contacts

What Are the Treatments Tested in This Trial?

Interventions

• High Ultra-Processed Food
• Low Ultra-Processed Food

Trial Overview The study tests if reducing ultra-processed food intake causes withdrawal symptoms that make it hard to stick with the diet. Participants will switch between high and low processed food diets while researchers monitor their cravings, stress responses, brain activity related to rewards, blood glucose levels, and overall ability to maintain the diet.

How Is the Trial Designed?

Group I: Self-Guided Low UP Food Diet Experimental Treatment 1 Intervention

Participants asked to eat a low UP food diet according to study provided nutritional guidance.

Group II: Meals Provided Low UP Food Diet Experimental Treatment 1 Intervention

.Participants asked to eat a low UP food diet provided by the study team.

Group III: Control Active Control 1 Intervention

Participants asked to eat as they usually do.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

University of Tasmania

Collaborator

Trials

13

Recruited

109,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Oregon Research Institute

Collaborator

Trials

87

Recruited

62,600+

Published Research Related to This Trial

Ultra-processed foods make up about 46% of daily energy intake in Germany and are linked to various non-communicable diseases such as obesity, diabetes, and cardiovascular disease.

The study highlights the need for intervention studies to better understand the mechanisms behind these associations and to improve dietary assessments in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What is ultra-processed food and how is it related to diet-related diseases?] Fedde, S., Rimbach, G., Schwarz, K., et al.[2022]

Ultraprocessed foods, which are high in added fats and refined carbohydrates, may have addictive properties similar to substance-use disorders, contributing to rising obesity and diet-related diseases.

Understanding food addiction through the lens of substance-use disorders could inform clinical and policy approaches, highlighting the need for further research, especially regarding the effects of these foods on children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Food Addictive? A Review of the Science. Gearhardt, AN., Schulte, EM.[2022]

In a study of 139 overweight children aged 9-11, 95% exhibited at least one symptom of food addiction, with 24% diagnosed with food addiction, highlighting a significant prevalence of this issue among this age group.

Consumption of ultra-processed foods, particularly cookies/biscuits and sausages, was found to be strongly associated with food addiction, suggesting that reducing these foods could be crucial in addressing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the consumption of ultra-processed foods and its association with food addiction in overweight children. Filgueiras, AR., Pires de Almeida, VB., Koch Nogueira, PC., et al.[2020]

In a study of 20 weight-stable adults over 4 weeks, participants consumed significantly more calories (508 kcal/day) while on an ultra-processed diet compared to an unprocessed diet, leading to weight gain.

The increased energy intake from ultra-processed foods was primarily due to higher carbohydrate and fat consumption, suggesting that reducing ultra-processed food intake could be a key strategy for preventing and treating obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Hall, KD., Ayuketah, A., Brychta, R., et al.[2021]

In a study of 260 schoolchildren aged 8 to 12 in Southeast Brazil, it was found that 25.2% of their daily caloric intake came from ultra-processed foods (UPF), which were linked to higher rates of overweight among the children.

Children who watched TV during meals and those who were overweight were significantly more likely to consume higher amounts of UPF, highlighting the need for nutritional interventions to promote healthier eating habits and prevent childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PARTICIPATION OF ULTRA-PROCESSED FOODS IN BRAZILIAN SCHOOL CHILDREN'S DIET AND ASSOCIATED FACTORS. Lacerda, AT., Carmo, ASD., Sousa, TM., et al.[2021]

A review of 43 studies found that 37 studies linked ultra-processed food (UPF) consumption to various adverse health outcomes, including obesity, type-2 diabetes, and cardiovascular diseases in adults, and cardio-metabolic risks in children.

No studies reported any beneficial health outcomes associated with UPF consumption, highlighting the need for dietary guidelines that consider the health risks of these foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods and Health Outcomes: A Narrative Review. Elizabeth, L., Machado, P., Zinöcker, M., et al.[2021]

Increasingly, dietary guidelines from governments and health organizations recommend choosing unprocessed or minimally processed foods over ultra-processed foods, as evidence links ultra-processed food consumption to poor diet quality and higher rates of chronic diseases.

Current research suggests that various characteristics of ultra-processed foods may negatively impact health through different physiological and behavioral mechanisms, supporting the recommendation to avoid these foods for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the concept of "ultra-processed foods" help inform dietary guidelines, beyond conventional classification systems? YES. Monteiro, CA., Astrup, A.[2023]

Ultra-processed foods, which are heavily modified and often contain additives, have been linked to lower nutritional quality and increased risks of chronic diseases such as cancer, cardiovascular disease, and obesity, based on numerous global studies.

Public health authorities are now recommending a reduction in the consumption of ultra-processed foods, but more research is needed to understand the mechanisms behind their health impacts and to inform regulations on food additives and processing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultra-processed food : from research to guidelines]. Srour, B., Chazelas, E., Touvier, M.[2022]

Approximately 20% of people worldwide may be addicted to ultra-processed foods, with prevalence rates varying significantly across different weight classes, suggesting a complex relationship between food addiction and body weight.

The study reveals a J-shaped curve in prevalence, indicating that underweight individuals may experience higher rates of ultra-processed food addiction, emphasizing the importance of considering mental health and eating disorders in treatment strategies rather than focusing solely on weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Considerations of Ultra-processed Food Addiction Across Weight Classes: an Eating Disorder Treatment and Care Perspective. Wiss, D.[2022]

In a study of 5946 Brazilian participants, those with food addiction (FA) consumed significantly less fresh fruits, vegetables, and beans, while having higher intakes of ultra-processed foods (UPF) like hamburgers and packaged snacks.

Eating patterns associated with FA included having meals in front of a screen and late-night snacking, while skipping breakfast was negatively associated with FA, suggesting that these habits could be targeted for clinical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between food addiction with ultra-processed food consumption and eating patterns in a Brazilian sample. Silva Júnior, AED., Gearhardt, AN., Bueno, NB.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11539364/

Using Less Processed Food to Mimic a Standard American ... The “clean eating” trend suggests that consuming fewer processed foods is important for healthy diets. Yet, a diet of mostly ultra-processed ...

2. bmj.com bmj.com/content/384/bmj-2023-077310

Ultra-processed food exposure and adverse health outcomes Greater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, common mental disorder, and ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1421728/full

Ultra-processed foods consumption and health-related ... Prospective observational studies have reported significant associations between higher intake of UPFs and adverse health outcomes.

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001365

Ultraprocessed Foods and Their Association With ... This science advisory reviews current evidence on UPFs and their impact on cardiometabolic health and outlines research needs, regulatory reform ...

5. eatrightpro.org eatrightpro.org/news-center/practice-trends/nutrition-fact-check-ultra-processed-foods

Nutrition Fact Check: Ultra-Processed Foods Additionally, a small randomized controlled trial demonstrated that a two-week diet of UPF meals increased ad libitum energy intake compared to unprocessed ...

6. nature.com nature.com/articles/s41591-025-03842-0

Ultraprocessed or minimally processed diets following ... Ultraprocessed food (UPF) consumption is associated with noncommunicable disease risk, yet no trial has assessed its health impact within ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7399967/

Ultra-Processed Foods and Health Outcomes: A Narrative ... 37 found dietary UPF exposure associated with at least one adverse health outcome. Among adults, these included overweight, obesity and cardio-metabolic risks.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11233771/

Ultra-processed foods consumption and health-related ... Prospective observational studies have reported significant associations between higher intake of UPFs and adverse health outcomes.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424001225

Ultra-processed foods and human health: An umbrella ... For observational studies, 2 health outcomes, including renal function decline (OR: 1.25; 95% CI: 1.18, 1.33) and wheezing in children and adolescents (OR: 1.42 ...