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

Trial Summary

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.

What data supports the effectiveness of the treatment 'Intake of nutritionally diverse ultra-processed foods' for obesity?

Research shows that high consumption of ultra-processed foods is linked to weight gain and a higher risk of obesity. Studies indicate that people who eat more ultra-processed foods tend to consume more calories and gain weight, suggesting that reducing these foods might help prevent or treat obesity. ^{1 2 3 4 5}

Is the consumption of ultra-processed foods generally safe for humans?

Research suggests that consuming ultra-processed foods is linked to higher risks of obesity, diabetes, and other chronic diseases. While these foods are not immediately harmful, their long-term consumption may negatively impact health, so it's recommended to limit their intake. ^{1 6 7 8 9}

How does the treatment of consuming nutritionally diverse ultra-processed foods differ from other obesity treatments?

This treatment is unique because it involves the intake of ultra-processed foods, which are typically linked to weight gain and obesity, rather than traditional methods that focus on reducing or eliminating such foods. The approach may explore how different types of ultra-processed foods impact obesity, offering insights into their role in weight management. ^{1 4 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods associated with weight gain and obesity in adults: A multi-national cohort study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. [2023]

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

Food insecurity and ultra-processed food consumption: the modifying role of participation in the Supplemental Nutrition Assistance Program (SNAP). [2023]

4. United States 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. [2023]

5. 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]

6. France pubmed.ncbi.nlm.nih.gov

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

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

Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods, Diet Quality and Human Health. [2023]

9. Switzerland 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. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in Obesity Prevalence Attributable to Ultra-Processed Food Consumption in Brazil Between 2002 and 2009. [2022]

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

Consumption of ultra-processed foods and obesity in Brazilian adolescents and adults. [2022]