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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn more about what happens in the human body after consuming a meal that contains ultra-processed foods like hamburgers, and if this is different to what happens after consuming a meal that contains lots of whole foods, like fresh vegetables, instead.

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.

What data supports the effectiveness of the treatment Ultra-processed Food Meal, Whole Food Meal for improving eating habits?

Research shows that people tend to eat more calories and gain weight when consuming ultra-processed foods compared to whole foods. Reducing ultra-processed food intake is linked to better weight management and lower risk of chronic diseases, suggesting that whole foods may promote healthier eating habits. ^{1 2 3 4 5}

Is it safe to consume ultra-processed foods?

Research shows that eating a lot of ultra-processed foods is linked to health problems like obesity, heart disease, and even a higher risk of death. It's generally recommended to avoid these foods for better health. ^{2 3 4 5 6}

How does the treatment of whole foods vs. ultra-processed foods differ from other dietary treatments?

This treatment is unique because it focuses on replacing ultra-processed foods, which are linked to poor health outcomes, with whole foods that are minimally processed. Unlike other dietary treatments that may focus on calorie counting or specific nutrients, this approach emphasizes the quality and processing level of the foods consumed. ^{2 4 7 8 9}

Research Team

Wilson Tang, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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 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]

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]

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. 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

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

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

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

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

Association Between Ultra-Processed Food Intake and All-Cause Mortality: A Systematic Review and Meta-Analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods and Health Outcomes: A Narrative Review. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Ultra-processed foods and obesity and adiposity parameters among children and adolescents: a systematic review. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed food products and diet quality among children, adolescents and adults in Belgium. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

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