Your session is about to expire
← Back to Search
Whole Foods vs. Processed Foods for Eating Habits (AMBER Trial)
N/A
Waitlist Available
Led By W. H. Wilson Tang, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to remain on a stable aspirin regimen (either on or off aspirin or aspirin products) for 1 week prior to starting study until the end of the study period.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Awards & highlights
AMBER Trial Summary
This trial will study the effects of consuming a meal of ultra-processed foods vs. a meal of whole foods on the human body.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves consuming regular meals (whole food or ultra-processed), there aren't typical side effects like in drug trials. However, participants may experience digestive discomfort depending on their individual reactions to the meal components.
AMBER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can maintain my current aspirin regimen without changes for the duration of the study.
AMBER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serial changes in plasma and urine TMAO
Serial changes in plasma and urine metabolites and biomarkers
AMBER Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm 4: Whole Food Meal + No AntibioticsExperimental Treatment1 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 floraExperimental Treatment1 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 AntibioticsExperimental Treatment1 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 floraExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,030 Total Patients Enrolled
W. H. Wilson Tang, MDPrincipal InvestigatorThe Cleveland Clinic
7 Previous Clinical Trials
1,895 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term stomach or intestine problem.I have had weight loss surgery like gastric banding or bypass.I have taken probiotics in the last month.I have not taken antibiotics or had an infection in the last 6 months.I can maintain my current aspirin regimen without changes for the duration of the study.I do not have any severe long-term illnesses like heart, kidney, lung problems, or blood diseases.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3: Whole Food Meal + Antibiotics to supress gut flora
- Group 2: Arm 2: Ultra-processed Meal + No Antibiotics
- Group 3: Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora
- Group 4: Arm 4: Whole Food Meal + No Antibiotics
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible for admission to this clinical experiment?
"Affirmative. The clinical trial is actively recruiting patients, as indicated on clinicaltrials.gov; it was first published on September 1st 2020 and recently updated on August 30th 2022, with the goal of enrolling 40 people from a single medical centre."
Answered by AI
Are there any current openings for participation in this clinical trial?
"According to the latest information retrieved from clinicaltrials.gov, this medical trial is actively looking for patients. This research was launched on September 1st 2020 and has been updated as recently as August 30th 2022."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger