Whole Foods vs. Processed Foods for Eating Habits
(AMBER Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Participants in certain arms take antibiotics for 3 days to suppress gut flora before the meal challenge
Meal Challenge
Participants consume either ultra-processed or whole food meals, with or without prior antibiotic treatment
Follow-up
Participants are monitored for changes in plasma and urine metabolites and biomarkers post-meal
What Are the Treatments Tested in This Trial?
Interventions
- Ultra-processed Food Meal
- Whole Food Meal
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor