Whole Foods vs. Processed Foods for Eating Habits

(AMBER Trial)

Overseen By Jennifer Wilcox, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Chronic illness, Gastrointestinal disorders, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different types of meals affect the body. It compares the effects of eating ultra-processed foods, such as hamburgers, to meals made with whole foods, like fresh vegetables. Some participants will also take antibiotics to study the role of gut bacteria. Ideal candidates for this trial can maintain a stable aspirin routine and have not recently taken antibiotics or probiotics. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on diet and gut health.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be able to stay on a stable aspirin regimen (either taking it or not) for 1 week before and during the study.

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

Research has shown that eating ultra-processed foods can harm gut health. These foods might alter the gut microbiome, the group of bacteria in the intestines, and increase the risk of diseases like heart problems. Some studies suggest that regularly consuming these foods could raise the risk of early death. Adding antibiotics can further upset the balance of gut bacteria, possibly leading to more health issues.

In contrast, whole foods are generally safer and healthier. They usually contain fewer harmful additives and benefit gut health. However, even with whole foods, antibiotics can still disrupt the balance of gut bacteria, potentially causing problems.

Prospective trial participants should understand the potential risks and benefits of both ultra-processed and whole foods, especially when antibiotics are involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the impact of whole foods versus ultra-processed foods on eating habits, with a unique twist. Unlike most studies that simply compare diets, this trial explores how gut flora suppression via antibiotics influences the body's response to these foods. The trial has four distinct approaches, including meals with and without antibiotics, to see how they affect digestion and health. By examining the gut's role, this study could shed light on how diet and gut health are intertwined, potentially paving the way for new dietary recommendations that go beyond current nutrition guidelines.

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

This trial will compare the effects of ultra-processed foods and whole foods on eating habits. Studies have shown that consuming ultra-processed foods, such as fast food hamburgers, links to higher risks of health problems, including heart disease and mental disorders. Research has found that people tend to consume more calories and expend more energy when eating these foods. Conversely, diets rich in whole foods, like fresh vegetables, link to better health outcomes. Eating whole foods associates with lower risks of diseases like diabetes and heart disease. These findings suggest that whole foods benefit health more than ultra-processed foods. Participants in this trial will be divided into different arms to assess these effects, with some receiving antibiotics to suppress gut flora before consuming either meal type. ^{6 7 8 9 10}

Who Is on the Research Team?

Wilson Tang, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 or older who can follow the study's rules. They must be able to stay on a stable aspirin regimen if they're taking it. People with food allergies, pregnant individuals, those with serious chronic diseases, recent antibiotic use, past bariatric surgeries, probiotic intolerance or usage are excluded.

Inclusion Criteria

Able to provide informed consent and comply with study protocol

I can maintain my current aspirin regimen without changes for the duration of the study.

Exclusion Criteria

I have a long-term stomach or intestine problem.

I have had weight loss surgery like gastric banding or bypass.

Intolerance to probiotic therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-treatment

Participants in certain arms take antibiotics for 3 days to suppress gut flora before the meal challenge

3 days

No visits required

Meal Challenge

Participants consume either ultra-processed or whole food meals, with or without prior antibiotic treatment

1 day

2 visits (in-person)

Follow-up

Participants are monitored for changes in plasma and urine metabolites and biomarkers post-meal

6 hours

Continuous monitoring during visit

What Are the Treatments Tested in This Trial?

Interventions

• Ultra-processed Food Meal
• Whole Food Meal

Trial Overview

The study compares bodily responses to two types of meals: one made entirely of whole foods like fresh veggies and another consisting of ultra-processed items such as hamburgers. The goal is to understand how these different meals affect our body's metabolism.

How Is the Trial Designed?

Group I: Arm 4: Whole Food Meal + No Antibiotics Experimental Treatment 1 Intervention

Subjects in Arm 4 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of whole, unprocessed foods.

Group II: Arm 3: Whole Food Meal + Antibiotics to supress gut flora Experimental Treatment 1 Intervention

Subjects in Arm 3 will take antibiotics for 3 days before the meal challenge to suppress the gut flora. The antibiotics to be used are: vancomycin, 125 mg three times daily; metronidazole, 500 mg twice daily; ciprofloxacin, 500 mg twice daily; and neomycin, 1 gram three times daily. These subjects will then consume a challenge meal of whole, unprocessed foods.

Group III: Arm 2: Ultra-processed Meal + No Antibiotics Experimental Treatment 1 Intervention

Subjects in Arm 2 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of ultra-processed foods.

Group IV: Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora Experimental Treatment 1 Intervention

Subjects in Arm 1 will take antibiotics for 3 days before the meal challenge to suppress the gut flora. The antibiotics to be used are: vancomycin, 125 mg three times daily; metronidazole, 500 mg twice daily; ciprofloxacin, 500 mg twice daily; and neomycin, 1 gram three times daily. These subjects will then consume a challenge meal of ultra-processed foods.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38418082/

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 ...

2.

eatrightpro.org

eatrightpro.org/news-center/practice-trends/nutrition-fact-check-ultra-processed-foods

Nutrition Fact Check: Ultra-Processed Foods

A 2024 umbrella systematic review and meta-analysis found convincing evidence that higher UPF intake was associated with increased risk of cardiovascular ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0939475325005812

Effectiveness and metabolic impacts of restricting the ...

They found greater energy consumption and expenditure in individuals when they instituted the diet with UPF. Additionally, individuals in the ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11174918/

Ultra-Processed Foods: A Narrative Review of the Impact on ...

This review summarizes the available research on the effect of UPFs on the gut microbiome. We also review current usage of the NOVA food classification system.

5.

ahajournals.org

ahajournals.org/doi/10.1161/CIR.0000000000001365

Ultraprocessed Foods and Their Association With ...

Although ultraprocessing or extensive processing can lower cost and improve shelf life, convenience, and taste of certain products, high UPF ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12232514/

Food Additives: Emerging Detrimental Roles on Gut Health

Various studies have identified that food additives can impact gut health by modulating gut microbiota and intensifying intestinal inflammation.

7.

mdpi.com

mdpi.com/2072-6643/17/5/859

The Detrimental Impact of Ultra-Processed Foods on ...

This review investigates how UPFs impact the gut microbiome and gut barrier, emphasizing gut dysbiosis and increased gut permeability.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S016041202500457X

Excessive ultra-processed foods exposure aggravates ...

Large cohort studies consistently associate Western-style diets rich in ultra-processed foods (UPFs) with elevated UC risk, whereas Mediterranean dietary ...

9.

bmj.com

bmj.com/company/newsroom/new-evidence-links-ultra-processed-foods-with-a-range-of-health-%20risks/

New evidence links ultra-processed foods with a range of ...

Results showed that higher consumption of ultra-processed foods (more than 4 servings per day) was associated with a 62% increased risk of all cause mortality ...

10.

microbiotajournal.com

microbiotajournal.com/wp-content/uploads/sites/7/2024/09/e1106.pdf

Effects of Food Additives on Gut Microbiota

Before they are approved for use in food, their safety is evaluated in a complex chemical risk assessment process based on data from animal and human studies ...