Whole Foods vs. Processed Foods for Eating Habits
(AMBER Trial)
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.12345
Is it safe to consume ultra-processed foods?
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.24789
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
Exclusion Criteria
Timeline
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
Treatment Details
Interventions
- Ultra-processed Food Meal
- Whole Food Meal
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor