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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are: • Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected. If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic 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 data supports the effectiveness of the Low-Processed Food Diet treatment?

Research shows that people who eat fewer ultra-processed foods tend to consume fewer calories and may lose weight, which suggests that a diet focusing on low-processed foods could help with weight management and potentially prevent obesity. ^{1 2 3 4 5}

Is a low-processed food diet safe for humans?

Research suggests that diets high in unprocessed or minimally processed foods are associated with better health outcomes and are generally considered safe. Avoiding ultra-processed foods is recommended to optimize health, as they are linked to various chronic diseases. ^{3 4 6 7 8}

How does the Low-Processed Food Diet treatment differ from other treatments for healthy eating?

The Low-Processed Food Diet is unique because it emphasizes consuming foods that are unprocessed or minimally processed, which is associated with higher diet quality and reduced risk of chronic diseases compared to diets high in ultra-processed foods. This approach is increasingly recommended in dietary guidelines to improve overall health by avoiding the negative effects of ultra-processed foods. ^{3 4 8 9 10}

Research Team

Sam Emerson, PhD

Principal Investigator

Oklahoma State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. 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]

2. United States 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. [2023]

3. United States 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. Switzerland 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. [2023]

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

Processed Foods - Getting Back to The Basics. [2021]

7. England pubmed.ncbi.nlm.nih.gov

How processed is the hospital menu? An analysis based on NOVA food scoring system. [2023]

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

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

9. Switzerland 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. [2022]

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

Ultra-Processed Food Consumption and Chronic Non-Communicable Diseases-Related Dietary Nutrient Profile in the UK (2008⁻2014). [2023]