Low-Processed Food Diet for Healthy Eating

Overseen By Tyler Godsey, B.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oklahoma State University

Disqualifiers: Chronic diseases, Tobacco use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a diet rich in unprocessed foods affects health compared to a typical Western diet. Participants will either follow a low-processed food diet or maintain their usual eating habits for six months. Researchers will collect health data to determine if the unprocessed diet improves metabolic health. Ideal participants live in rural areas, are not very active, and consume a Western diet high in processed foods. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on diet and health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dietary changes rather than medication use.

What prior data suggests that this diet is safe?

Research shows that eating less processed food links to better health. Studies have found that diets high in ultra-processed foods can increase the risk of heart problems, mental health issues, and even death. One study discovered that people who ate more processed foods consumed 500 extra calories a day and gained weight. Although no direct study exists on diets low in processed foods, these findings suggest that eating less processed food could be safer and healthier.

Since this trial isn't testing a new drug or medical procedure, no known safety concerns exist. Eating less processed food is generally safe. However, it can be more expensive and requires more frequent shopping because these foods spoil faster. Overall, switching to a diet with less processed food seems promising for improving health without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Low-Processed Food Diet because it focuses on eating whole, minimally processed foods, which could be a game-changer for promoting healthy eating habits. Unlike typical diets that may include processed options, this diet emphasizes natural ingredients, potentially leading to improved nutrition and overall well-being. By cutting out highly processed foods, the diet may help reduce the risk of chronic diseases and support better weight management. This approach is thought to be more sustainable and health-boosting compared to standard eating habits that rely heavily on convenience and processed foods.

What evidence suggests that a low-processed food diet could improve metabolic health?

This trial will compare a Low-Processed Food Diet with a Typical Diet. Research has shown that eating fewer processed foods can improve health. Studies have found that people who consume less processed food typically eat fewer calories and gain less weight than those who consume more. One study found that participants on a diet with fewer processed foods lost weight twice as fast as those who ate more processed foods. Additionally, eating natural, whole foods can help the body convert food into energy more efficiently. These findings suggest that focusing on unprocessed foods can help maintain a healthy weight and improve overall health. ^{1 2 3 6 7}

Who Is on the Research Team?

Sam Emerson, PhD

Principal Investigator

Oklahoma State University

Are You a Good Fit for This Trial?

This trial is for individuals interested in healthy eating. Participants will either continue their normal diet or switch to a low-processed food diet for 6 months. To join, they must be willing to follow dietary instructions and have health data collected.

Inclusion Criteria

Rural county resident

Consuming a typical Western diet (rich in UPF)

Not meeting physical activity guidelines for adults

Exclusion Criteria

History of tobacco, vape, or illicit drug use

Overly active

Already on a restrictive diet (e.g., keto, intermittent fasting)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are instructed to consume either a diet rich in unprocessed food or their typical diet for 6 months

6 months

Metabolic health data collected at various points

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Low-Processed Food Diet

Trial Overview The study tests the impact of a low-processed food diet on metabolic health compared to a typical diet. Participants are randomly assigned to one of the two diets, with regular check-ins over six months to monitor changes in their metabolic health.

How Is the Trial Designed?

Group I: Low-Processed Food Group Experimental Treatment 1 Intervention

Group II: Typical Diet Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Oklahoma State University

Lead Sponsor

Trials

51

Recruited

8,600+

Published Research Related to This Trial

More than half of daily energy intake in many western countries comes from processed and ultra-processed foods, which are linked to serious health issues like obesity, metabolic syndrome, cardiovascular diseases, and certain cancers.

Recent research is enhancing our understanding of how processed foods negatively impact health, suggesting a need for comprehensive public health strategies to address this growing concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processed Foods - Getting Back to The Basics. Mohamed Elfadil, O., Patel, J., Patel, I., et al.[2021]

The study found that hospital menus contained 25.2% of energy from ultra-processed foods (UPF), which are linked to lower nutrient density, highlighting a potential issue in hospital nutrition.

In contrast, minimally processed foods (MPF) and processed culinary ingredients (PCI) were associated with higher energy, protein, and essential micronutrients, suggesting that increasing these foods in hospital diets could help combat malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How processed is the hospital menu? An analysis based on NOVA food scoring system. Detopoulou, P., Panoutsopoulos, GI.[2023]

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]

Higher intake of unprocessed and minimally processed foods (UMP) is linked to improved diet quality metrics over 3 decades in two large cohorts of health professionals, with significant increases in scores for healthy eating indices.

In contrast, higher consumption of ultraprocessed foods (UPF) is associated with lower diet quality, indicating that UMP consumption promotes healthier eating patterns while UPF consumption detracts from them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intakes of Unprocessed and Minimally Processed and Ultraprocessed Food Are Associated with Diet Quality in Female and Male Health Professionals in the United States: A Prospective Analysis. Rossato, SL., Khandpur, N., Lo, CH., et al.[2023]

The semi-quantitative food frequency questionnaire (SFFQ) demonstrated acceptable validity in estimating energy intake from both unprocessed/minimally processed foods and ultra-processed foods among 226 Mexican adults, regardless of age group.

Correlation coefficients indicated a stronger relationship for ultra-processed foods (0.67 for adults <60 years and 0.48 for adults ≥60 years) compared to unprocessed/minimally processed foods, suggesting that the SFFQ is particularly effective for assessing intake of ultra-processed foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Semi-quantitative Food Frequency Questionnaire Has Relative Validity to Identify Groups of NOVA Food Classification System Among Mexican Adults. Oviedo-Solís, CI., Monterrubio-Flores, EA., Rodríguez-Ramírez, S., et al.[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]

A study of 25,351 participants from the 2003-2008 NHANES found that all levels of processed foods contribute to nutrient intakes, indicating that processed foods are a significant part of American diets.

The level of food processing was found to be a minor factor in determining the nutrient contribution of individual foods, suggesting that focusing solely on processing levels may not be the best approach for selecting a balanced diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contributions of processed foods to dietary intake in the US from 2003-2008: a report of the Food and Nutrition Science Solutions Joint Task Force of the Academy of Nutrition and Dietetics, American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. Eicher-Miller, HA., Fulgoni, VL., Keast, DR.[2023]

In the U.K. diet, ultra-processed foods account for a staggering 56.8% of total calorie intake, which is linked to higher levels of unhealthy nutrients like free sugars, saturated fats, and sodium, while reducing beneficial nutrients like protein and fiber.

Reducing the consumption of ultra-processed foods could significantly enhance dietary quality and help prevent chronic non-communicable diseases, as those consuming more ultra-processed foods showed an 85% increase in exceeding recommended limits for free sugars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Food Consumption and Chronic Non-Communicable Diseases-Related Dietary Nutrient Profile in the UK (2008⁻2014). Rauber, F., da Costa Louzada, ML., Steele, EM., 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]

High consumption of ultra-processed foods before a cancer diagnosis is linked to an increased risk of all-cause mortality in lung and prostate cancer patients, suggesting that diet may impact survival outcomes.

Specifically, colorectal cancer patients in early stages (I and II) and prostate cancer patients with a lower body mass index (<25) showed a significant association between ultra-processed food intake and cancer-specific mortality, indicating that dietary choices may influence prognosis in certain subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediagnosis ultra-processed food consumption and prognosis of patients with colorectal, lung, prostate, or breast cancer: a large prospective multicenter study. Pu, JY., Xu, W., Zhu, Q., et al.[2023]

Citations

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

Ultraprocessed or minimally processed diets following ... To date, two RCTs demonstrate unfavorable weight changes on UPF compared with MPF diets matched for presented energy and nutrients, but no RCTs ...

2. 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 ...

3. nutritionsource.hsph.harvard.edu nutritionsource.hsph.harvard.edu/processed-foods/

Processed Foods and Health - The Nutrition Source The diets were relatively equal in calories, sugar, fat, fiber, and other nutrients, and participants were allowed to eat as much or as little as they liked.

4. bmj.com bmj.com/content/390/bmj.r1644

Less processed diet could help adults lose weight twice as ... Less processed diet could help adults lose weight twice as quickly, study reports ... Researchers at University College London and UCL Hospitals ...

5. cc.nih.gov cc.nih.gov/news/2019/summer/story-01

First randomized, controlled study finds ultra-processed ... The study found that people who ate processed food ate more calories and gained more weight than when they consumed a whole food diet with foods that were ...

6. 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 ...

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

Ultraprocessed Foods and Their Association With ... High versus low UPF intake was linked to a 25% to 58% higher risk of cardiometabolic outcomes and a 21% to 66% higher risk of mortality.