Dietary HabitsAMBERNCT04308473
Analysis of MicroBial Metabolites After Eating Refined Food
A study testing Ultra-processed Food Meal and Whole Food Meal in people with Dietary Habits, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Ultra-processed Food Meal and Whole Food Meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women age 18 years or above.
- Able to provide informed consent and comply with study protocol
- 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.
Who cannot join
- Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
- Active infection or received antibiotics within 6 months of study enrollment.
- Use of over-the-counter probiotic within past month.
- Chronic gastrointestinal disorders.
- Intolerance to probiotic therapy.
- Allergy to vancomycin, ciprofloxacin, neomycin, metronidazole, or lactose.
Show all 9Show fewer
- Allergy to any of the food components of the challenge meals.
- Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The purpose of this study is to discover more about how the human body and the bacteria living in our intestines, known as "gut flora," react to different foods a person may consume. The investigators want to know if there are differences in compounds measured in a participant's blood and urine after eating different foods. Specifically, the investigators are interested in seeing if there are differences in these compounds after eating ultra-processed foods, like hamburgers and french fries, versus eating whole foods, like fresh fruits and vegetables. The investigators also want to know if the bacteria in our intestines may change the levels of these compounds. To this end, some subjects will be asked to take antibiotics to suppress the gut flora for three days before eating the challenge meal. Suppression of gut flora is a known effect of the antibiotics used in this study. Participants will have two study visits.
- Conditions
- Dietary Habits
- Being tested
- Ultra-processed Food Meal, Whole Food Meal
- Keywords
- Gastrointestinal Microbiome, Ultra-processed Food
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-processed Food MealOther
An ultra-processed diet challenge test utilizing 1) potatoes fried in highly refined and processed vegetable oil, including corn, soybean, or canola oil, with wheat and milk derivatives; 2) a beef patty sandwich containing processed American cheese, enriched refined flour, mold inhibitor, preservatives and oxidation/reduction additives such as ascorbic acid, potassium/calcium iodate, alpha-amylase, and azodicarbonamide; and 3) a beverage composed of carbonated water, high fructose corn syrup and caramel coloring. The ultra-processed challenge meal will be obtained from a local restaurant on the day of the challenge test.
Whole Food MealOther
A whole food diet challenge test utilizing 1) a side salad comprised of fresh leafy vegetables, and typical whole food toppings including fresh onion, fresh tomato, fresh carrots, and raw walnuts with a pure unrefined olive oil salad dressing; 2) a legume-based main dish including chickpeas, lentils and whole grain quinoa; 3) a fresh berry-rich smoothie beverage consisting of organic blueberries, raspberries, strawberries, bananas, and fresh orange juice. The whole food challenge meal will be made by the study team from readily available commercial foods bought from local grocery stores.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora | Experimental | 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. Receives: Other: Ultra-processed Food Meal |
| Arm 2: Ultra-processed Meal + No Antibiotics | Experimental | Subjects in Arm 2 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of ultra-processed foods. Receives: Other: Ultra-processed Food Meal |
| Arm 3: Whole Food Meal + Antibiotics to supress gut flora | Experimental | 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. Receives: Other: Whole Food Meal |
| Arm 4: Whole Food Meal + No Antibiotics | Experimental | Subjects in Arm 4 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of whole, unprocessed foods. Receives: Other: Whole Food Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial changes in plasma and urine metabolites and biomarkers
Serial changes in plasma and urine metabolites and biomarkers
Measured: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Serial changes in plasma and urine TMAO
Serial changes in plasma and urine TMAO (trimethylamine N-oxide)
Measured: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Sep 2020
- Primary completion28 Feb 2023
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 = Ultra-Processed Food Meal + Antibiotics to suppress gut flora; Group 2 = Ultra-Processed Food Meal with No Antibiotics; Group 3 = Whole Food Meal + Antibiotics to suppress gut flora; Group 4 = Whole Food Meal with No Antibiotics
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Tang, The Cleveland Clinic
- Investigators
- W. H. Wilson Tang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308473
- Sponsor's protocol ID
- 19-1623
- Acronym
- AMBER
- Status last verified
- Jun 2026
- First submitted
- 2 Mar 2020
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
PubMed 23614584Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
PubMed 21475195Schugar RC, Shih DM, Warrier M, Helsley RN, Burrows A, Ferguson D, Brown AL, Gromovsky AD, Heine M, Chatterjee A, Li L, Li XS, Wang Z, Willard B, Meng Y, Kim H, Che N, Pan C, Lee RG, Crooke RM, Graham MJ, Morton RE, Langefeld CD, Das SK, Rudel LL, Zein N, McCullough AJ, Dasarathy S, Tang WHW, Erokwu BO, Flask CA, Laakso M, Civelek M, Naga Prasad SV, Heeren J, Lusis AJ, Hazen SL, Brown JM. The TMAO-Producing Enzyme Flavin-Containing Monooxygenase 3 Regulates Obesity and the Beiging of White Adipose Tissue. Cell Rep. 2017 Jun 20;19(12):2451-2461. doi: 10.1016/j.celrep.2017.05.077.
PubMed 28636934Koh A, De Vadder F, Kovatcheva-Datchary P, Backhed F. From Dietary Fiber to Host Physiology: Short-Chain Fatty Acids as Key Bacterial Metabolites. Cell. 2016 Jun 2;165(6):1332-1345. doi: 10.1016/j.cell.2016.05.041.
PubMed 27259147Srour B, Fezeu LK, Kesse-Guyot E, Alles B, Mejean C, Andrianasolo RM, Chazelas E, Deschasaux M, Hercberg S, Galan P, Monteiro CA, Julia C, Touvier M. Ultra-processed food intake and risk of cardiovascular disease: prospective cohort study (NutriNet-Sante). BMJ. 2019 May 29;365:l1451. doi: 10.1136/bmj.l1451.
PubMed 31142457Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
PubMed 31105044Tang ZZ, Chen G, Hong Q, Huang S, Smith HM, Shah RD, Scholz M, Ferguson JF. Multi-Omic Analysis of the Microbiome and Metabolome in Healthy Subjects Reveals Microbiome-Dependent Relationships Between Diet and Metabolites. Front Genet. 2019 May 17;10:454. doi: 10.3389/fgene.2019.00454. eCollection 2019.
PubMed 31164901
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of MicroBial Metabolites After Eating Refined Food
- ClinicalTrials.gov ID
- NCT04308473
- Acronym / sponsor ID
- AMBER / 19-1623
- Conditions
- Dietary Habits
- Keywords
- Gastrointestinal Microbiome, Ultra-processed Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to discover more about how the human body and the bacteria living in our intestines, known as "gut flora," react to different foods a person may consume. The investigators want to know if there are differences in compounds measured in a participant's blood and urine after eating different foods. Specifically, the investigators are interested in seeing if there are differences in these compounds after eating ultra-processed foods, like hamburgers and french fries, versus eating whole foods, like fresh fruits and vegetables. The investigators also want to know if the bacteria in our intestines may change the levels of these compounds. To this end, some subjects will be asked to take antibiotics to suppress the gut flora for three days before eating the challenge meal. Suppression of gut flora is a known effect of the antibiotics used in this study. Participants will have two study visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Group 1 = Ultra-Processed Food Meal + Antibiotics to suppress gut flora; Group 2 = Ultra-Processed Food Meal with No Antibiotics; Group 3 = Whole Food Meal + Antibiotics to suppress gut flora; Group 4 = Whole Food Meal with No Antibiotics
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora | Experimental | Other: Ultra-processed Food MealSubjects 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. |
| Arm 2: Ultra-processed Meal + No Antibiotics | Experimental | Other: Ultra-processed Food MealSubjects in Arm 2 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of ultra-processed foods. |
| Arm 3: Whole Food Meal + Antibiotics to supress gut flora | Experimental | Other: Whole Food MealSubjects 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. |
| Arm 4: Whole Food Meal + No Antibiotics | Experimental | Other: Whole Food MealSubjects in Arm 4 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of whole, unprocessed foods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women age 18 years or above.
- Able to provide informed consent and comply with study protocol
- 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.
Key exclusion criteria (9 listed)
- Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
- Active infection or received antibiotics within 6 months of study enrollment.
- Use of over-the-counter probiotic within past month.
- Chronic gastrointestinal disorders.
- Intolerance to probiotic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-processed Food MealAn ultra-processed diet challenge test utilizing 1) potatoes fried in highly refined and processed vegetable oil, including corn, soybean, or canola oil, with wheat and milk derivatives; 2) a beef patty sandwich containing processed American cheese, enriched refined flour, mold inhibitor, preservatives and oxidation/reduction additives such as ascorbic acid, potassium/calcium iodate, alpha-amylase, and azodicarbonamide; and 3) a beverage composed of carbonated water, high fructose corn syrup and caramel coloring. The ultra-processed challenge meal will be obtained from a local restaurant on the day of the challenge test. | Other | Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora, Arm 2: Ultra-processed Meal + No Antibiotics |
| Whole Food MealA whole food diet challenge test utilizing 1) a side salad comprised of fresh leafy vegetables, and typical whole food toppings including fresh onion, fresh tomato, fresh carrots, and raw walnuts with a pure unrefined olive oil salad dressing; 2) a legume-based main dish including chickpeas, lentils and whole grain quinoa; 3) a fresh berry-rich smoothie beverage consisting of organic blueberries, raspberries, strawberries, bananas, and fresh orange juice. The whole food challenge meal will be made by the study team from readily available commercial foods bought from local grocery stores. | Other | Arm 3: Whole Food Meal + Antibiotics to supress gut flora, Arm 4: Whole Food Meal + No Antibiotics |
Primary outcome
Serial changes in plasma and urine metabolites and biomarkers
Time frame: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Serial changes in plasma and urine metabolites and biomarkers
Serial changes in plasma and urine TMAO
Time frame: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Serial changes in plasma and urine TMAO (trimethylamine N-oxide)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 23614584Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
- Background: PubMed 21475195Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
- Background: PubMed 28636934Schugar RC, Shih DM, Warrier M, Helsley RN, Burrows A, Ferguson D, Brown AL, Gromovsky AD, Heine M, Chatterjee A, Li L, Li XS, Wang Z, Willard B, Meng Y, Kim H, Che N, Pan C, Lee RG, Crooke RM, Graham MJ, Morton RE, Langefeld CD, Das SK, Rudel LL, Zein N, McCullough AJ, Dasarathy S, Tang WHW, Erokwu BO, Flask CA, Laakso M, Civelek M, Naga Prasad SV, Heeren J, Lusis AJ, Hazen SL, Brown JM. The TMAO-Producing Enzyme Flavin-Containing Monooxygenase 3 Regulates Obesity and the Beiging of White Adipose Tissue. Cell Rep. 2017 Jun 20;19(12):2451-2461. doi: 10.1016/j.celrep.2017.05.077.
- Background: PubMed 27259147Koh A, De Vadder F, Kovatcheva-Datchary P, Backhed F. From Dietary Fiber to Host Physiology: Short-Chain Fatty Acids as Key Bacterial Metabolites. Cell. 2016 Jun 2;165(6):1332-1345. doi: 10.1016/j.cell.2016.05.041.
- Background: PubMed 31142457Srour B, Fezeu LK, Kesse-Guyot E, Alles B, Mejean C, Andrianasolo RM, Chazelas E, Deschasaux M, Hercberg S, Galan P, Monteiro CA, Julia C, Touvier M. Ultra-processed food intake and risk of cardiovascular disease: prospective cohort study (NutriNet-Sante). BMJ. 2019 May 29;365:l1451. doi: 10.1136/bmj.l1451.
- Background: PubMed 31105044Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
- Background: PubMed 31164901Tang ZZ, Chen G, Hong Q, Huang S, Smith HM, Shah RD, Scholz M, Ferguson JF. Multi-Omic Analysis of the Microbiome and Metabolome in Healthy Subjects Reveals Microbiome-Dependent Relationships Between Diet and Metabolites. Front Genet. 2019 May 17;10:454. doi: 10.3389/fgene.2019.00454. eCollection 2019.
- Individual participant dataSharing planned: No
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Dietary Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. H. Wilson Tang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-processed Food Meal and Whole Food Meal in people with Dietary Habits, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial changes in plasma and urine metabolites and biomarkers (time frame: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308473, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.