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

Trial Summary

What is the purpose of this trial?

This study experimentally investigates whether a reduction in ultra-processed (UP) food intake (1) causes aversive withdrawal symptoms in humans, (2) increases the motivational salience of UP food cues and, if so, (3) whether these factors undermine the ability to adhere to a low-UP diet. The following aims and hypotheses are tested: Aim 1: To investigate whether aversive physical, cognitive, and affective withdrawal symptoms emerge in response to reduced UP food intake compared to a high-UP diet, and whether this predicts failure to adhere to a low-UP diet. H1a: Reducing UP food intake will result in aversive physical, cognitive, and affective withdrawal symptoms, as indicated by 1) ecological momentary assessment (EMA) reports of aversive withdrawal symptoms, and 2) heart rate reactivity and subjective distress to an in-lab stressor. H1b: Aversive symptoms of UP food withdrawal will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet. Aim 2: To investigate whether increased motivational salience of UP food cues emerges in response to reduced UP food intake, and whether this predicts failure to maintain a low-UP diet. H2a: Reducing UP food intake will result in increased motivational salience of UP food cues, as indicated by 1) EMA reports of UP food craving, 2) heart rate reactivity and subjective craving in a simulated fast-food restaurant, 3) heightened reinforcement value for UP food relative to other reinforcers, and 4) greater reward-related neural response to UP food cues. H2b: Increased motivational salience of UP food cues will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet.

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.

What data supports the effectiveness of the treatment for food addiction?

Research shows that high consumption of ultra-processed foods is linked to food addiction, and reducing these foods in favor of whole, minimally processed foods is recommended to improve health. Studies suggest that ultra-processed foods can be addictive, similar to substances, and avoiding them may help manage food addiction. ^{1 2 3 4 5}

Is it safe to follow a diet low in ultra-processed foods?

Research suggests that reducing ultra-processed foods in your diet is generally safe and may even improve health by lowering the risk of chronic diseases like obesity, diabetes, and heart disease. ^{2 6 7 8 9}

How does the treatment of dietary changes for food addiction differ from other treatments?

This treatment is unique because it focuses on reducing the intake of ultra-processed foods, which are linked to addictive eating behaviors and various health issues, unlike other treatments that may not specifically target food processing levels. By promoting a diet low in ultra-processed foods, it aims to address the root cause of food addiction and its associated health problems. ^{2 3 5 8 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Exploring the consumption of ultra-processed foods and its association with food addiction in overweight children. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Association between food addiction with ultra-processed food consumption and eating patterns in a Brazilian sample. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Is Food Addictive? A Review of the Science. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

PARTICIPATION OF ULTRA-PROCESSED FOODS IN BRAZILIAN SCHOOL CHILDREN'S DIET AND ASSOCIATED FACTORS. [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Ultra-processed food : from research to guidelines]. [2022]

8. United States 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. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods and Health Outcomes: A Narrative Review. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[What is ultra-processed food and how is it related to diet-related diseases?] [2022]