Ultra-Processed Foods' Impact on Obesity

Overseen By Erica M. LaFata, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Metformin, Liraglutide

Disqualifiers: Diabetes, Hypertension, Cardiovascular events, others

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

Compensation: Varies

Number of Visits: 5

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different ingredients in ultra-processed foods (UPFs) might link to overeating and obesity. Researchers will examine how foods high in fat, refined carbohydrates (like sugar), or both affect enjoyment and bodily reactions. Participants will try various UPFs to determine which ones are more satisfying or lead to increased consumption. Individuals with a body mass index (BMI) of 30 or above, who enjoy UPFs, and reside in the Philadelphia area might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and health.

Will I have to stop taking my current medications?

The trial excludes people who are currently using medications that might affect metabolism or appetite, like metformin or liraglutide. If you're taking such medications, you would not be eligible to participate.

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

Research shows that eating ultra-processed foods (UPFs) links to several health issues. Studies have found that UPFs high in fat connect to higher risks of health problems. These foods often pack many calories into small portions, leading to weight gain.

Similarly, UPFs high in refined carbohydrates also link to higher risks of obesity and other health issues. People who consume more of these foods tend to have higher body mass indexes (BMI) and are more likely to be obese.

Both types of UPFs—those high in fat and those high in refined carbohydrates—are known for their appealing taste, which makes overeating easy. This overeating can lead to various health problems, including obesity.

The evidence consistently shows that a diet high in UPFs can lead to more than 30 different health conditions. While the foods tested in the trial are common in many diets, they also link to several health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different types of ultra-processed foods (UPFs) affect obesity, a growing concern worldwide. Unlike traditional dietary interventions focusing on calorie count and balanced nutrients, this study looks at how UPFs high in fat, refined carbohydrates, or both impact weight differently. The trial also compares these foods to minimally processed options, providing insights into how processing level affects weight gain. Understanding these differences could lead to more effective dietary recommendations and interventions for obesity management.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will examine the impact of different types of ultra-processed foods (UPFs) on obesity. Participants will join one of several treatment arms. Research has shown that eating UPFs can lead to weight gain. One study found that people who ate UPFs high in both fat and refined carbohydrates gained about 2 pounds. Another study showed that these foods caused an average weight gain of 1.1 kg and led to increased calorie intake. Participants in this trial may receive UPFs high in fat, which have been shown to cause weight gain and increased body fat. Others may receive UPFs high in refined carbohydrates, which have been linked to higher body mass index (BMI) and a greater chance of obesity. Overall, eating UPFs, regardless of the mix of fat and carbohydrates, tends to cause weight gain and related health risks. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with obesity (BMI ≥ 30 kg/m2) who enjoy certain snack foods and can attend six sessions in Philadelphia. Participants must be able to use a smartphone. Exclusions include non-English speakers, recent significant weight loss or cardiovascular events, certain medication users, those with severe mood disorders or eating disorders, substance abuse issues, diabetes or hypertension diagnosis, and women who are nursing or pregnant.

Inclusion Criteria

You have a body mass index (BMI) of 30 or higher.

I like the test snack foods at least a 6 out of 10.

Live in the greater Philadelphia area and are willing/able to participate in six in-person assessments

Exclusion Criteria

You currently have a drug or alcohol addiction.

I do not have or am unwilling to use a smartphone.

You have lost more than 5% of your body weight in the past 6 months and this may affect your food preferences.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including behavioral tasks to evaluate risk factors for enhanced ultra-processed food reward

1 week

1 visit (in-person)

Food Consumption Appointments

Participants attend four appointments to consume different types of ultra-processed and minimally processed foods, with assessments of subjective experiences and metabolic responses

4 weeks

4 visits (in-person)

Ecological Momentary Assessment (EMA)

Participants complete EMA surveys to assess subjective experiences and real-world food consumption over 5 days following each food consumption appointment

20 days

Follow-up

Participants are monitored for safety and effectiveness after the main trial activities, including follow-up assessments of risk factors

1-2 months

What Are the Treatments Tested in This Trial?

Interventions

• Intake of nutritionally diverse ultra-processed foods

Trial Overview The study investigates how different ingredients in ultra-processed foods (high in fat or refined carbohydrates) affect the body's reward responses and contribute to overeating and obesity. It aims to identify which aspects of these foods make them more likely to cause compulsive eating by examining physiological and metabolic reactions.

How Is the Trial Designed?

Group I: UPF high in refined carbohydrates Experimental Treatment 1 Intervention

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

Group II: UPF high in fat and refined carbohydrates Experimental Treatment 1 Intervention

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

Group III: UPF high in fat Experimental Treatment 1 Intervention

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

Group IV: MPF high in fat or carbohydrates Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Published Research Related to This Trial

In a study of 110,260 adults from the NutriNet-Santé cohort, higher consumption of ultra-processed foods (UPF) was linked to significant increases in body mass index (BMI) and a greater risk of becoming overweight or obese.

For every 10% increase in UPF intake, the risk of overweight increased by 11% and the risk of obesity by 9%, even after accounting for various lifestyle and dietary factors, highlighting the potential health risks associated with UPF consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed food intake in association with BMI change and risk of overweight and obesity: A prospective analysis of the French NutriNet-Santé cohort. Beslay, M., Srour, B., Méjean, C., et al.[2023]

A systematic review of 17 studies indicates that the consumption of ultra-processed foods (UPF) is significantly associated with an increased risk of general and abdominal obesity.

There is also evidence suggesting that UPF consumption may elevate the risk of cardiometabolic issues, such as hypertension, diabetes, and dyslipidemia, although more research is needed to fully understand these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Food Consumption and Incidence of Obesity and Cardiometabolic Risk Factors in Adults: A Systematic Review of Prospective Studies. Mambrini, SP., Menichetti, F., Ravella, S., et al.[2023]

In a study of 9,190 adults with incomes ≤300% of the federal poverty level, higher levels of food insecurity were linked to increased consumption of ultra-processed foods, with intake rising from 52.6% for those with high food security to 55.7% for those with very low food security.

Participation in the Supplemental Nutrition Assistance Program (SNAP) was also associated with higher ultra-processed food intake (54.7%), but the relationship between food insecurity and ultra-processed food consumption was not significant among SNAP participants, suggesting that SNAP may influence dietary choices differently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food insecurity and ultra-processed food consumption: the modifying role of participation in the Supplemental Nutrition Assistance Program (SNAP). Leung, CW., Fulay, AP., Parnarouskis, L., et al.[2023]

Between 2002 and 2009, Brazil saw an increase in obesity prevalence from 9.9% to 13.2%, which was significantly linked to the rise in consumption of ultra-processed foods, which increased from 14.3% to 17.3% of total energy intake.

The study found that over 28.6% of the increase in obesity prevalence during this period could be attributed to the higher consumption of ultra-processed foods, highlighting their major role in the obesity epidemic in Brazil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Obesity Prevalence Attributable to Ultra-Processed Food Consumption in Brazil Between 2002 and 2009. Louzada, ML., Steele, EM., Rezende, LFM., et al.[2022]

In a study of 30,243 Brazilian adults and adolescents, it was found that ultra-processed foods accounted for 30% of total energy intake, indicating a significant presence in the diet.

Individuals consuming the highest amounts of ultra-processed foods had a higher body mass index and were nearly twice as likely to be obese compared to those consuming the least, highlighting a strong link between ultra-processed food consumption and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and obesity in Brazilian adolescents and adults. Louzada, ML., Baraldi, LG., Steele, EM., et al.[2022]

In a study of 348,748 adults from 9 European countries, higher consumption of ultra-processed foods (UPF) was linked to a significant weight gain of 0.12 kg over 5 years, indicating a potential risk factor for obesity.

Participants in the highest quintile of UPF consumption had a 15% increased risk of becoming overweight and a 16% increased risk of obesity compared to those in the lowest quintile, highlighting the need for public health initiatives to promote less processed food options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods associated with weight gain and obesity in adults: A multi-national cohort study. Cordova, R., Kliemann, N., Huybrechts, I., et al.[2022]

High consumption of ultra-processed foods (UPF) is linked to a significant increase in the risk of overweight/obesity (39%), high waist circumference (39%), and metabolic syndrome (79%) based on a systematic review of 23 studies.

In a large cohort of 183,491 participants followed for 3.5 to 19 years, high UPF consumption was associated with a 25% increased risk of all-cause mortality and a 29% increased risk of cardiovascular disease, indicating serious long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. Pagliai, G., Dinu, M., Madarena, MP., et al.[2023]

This systematic review and meta-analysis of 12 observational studies found that higher consumption of ultra-processed foods (UPF) is significantly associated with an increased risk of obesity (odds ratio of 1.55) and overweight (odds ratio of 1.36) in the general population.

Every 10% increase in UPF consumption in daily calorie intake correlates with a 7% higher risk of overweight, a 6% higher risk of obesity, and a 5% higher risk of abdominal obesity, indicating a clear link between UPF intake and excess weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis. Moradi, S., Entezari, MH., Mohammadi, H., et al.[2022]

The rise in consumption of ultra-processed foods (UPF) is linked to a growing prevalence of obesity and non-communicable diseases worldwide, indicating potential health risks associated with these products.

This correlation suggests that the increasing volume of industrially processed foods in the global food supply may negatively impact human health, warranting further investigation into dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods, Diet Quality and Human Health. Dinu, M., Martini, D.[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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7946062/

Ultra-processed diets cause excess calorie intake and ... In conclusion, our data suggest that eliminating ultra-processed foods from the diet decreases energy intake and results in weight loss whereas a diet with a ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323002910

Ultraprocessed Foods and Obesity Risk: A Critical Review ... This review identified no mechanistic evidence directly linking ultraprocessed food intake with increased body mass index.

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

Ultra-processed foods consumption and health-related ... Fat mass increased by 0.4 ± 0.1 kg during the ultra-processed diet (p = 0.0015), with no significant changes during the unprocessed diet. No ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15922

Ultra‐processed foods cause weight gain and increased ... All participants completed the study. During the UPF period, participants gained 1.1 kg more weight (95% confidence interval 0.2 to 2.0; P = .

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10924027/

Ultra-processed Food and Obesity: What Is the Evidence? - PMC UPFs tend to be more energy dense than MPFs or PFs [47, 48], containing unique 'hyperpalatable' combinations of carbohydrate, fat and salt that ...

7. med.stanford.edu med.stanford.edu/news/insights/2025/07/ultra-processed-food--five-things-to-know.html

Ultra-processed food: Five things to know - Stanford Medicine ... foods, drinks and snacks that were high in fat ... highly processed foods is clearly associated with a higher risk of adverse health outcomes.

8. ama-assn.org ama-assn.org/public-health/prevention-wellness/what-doctors-wish-patients-knew-about-ultraprocessed-foods

What doctors wish patients knew about ultraprocessed foods “High amounts of added fat and sugar added to ultraprocessed creations make them considerably more calorie-dense than most whole foods,” said Dr. Devries ...