Study 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.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Hour 6
Serial changes in plasma and urine TMAO
Serial changes in plasma and urine metabolites and biomarkers
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
4 Treatment Groups
Arm 2: Ultra-processed Meal + No Antibiotics
1 of 4
Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora
1 of 4
Arm 3: Whole Food Meal + Antibiotics to supress gut flora
1 of 4
Arm 4: Whole Food Meal + No Antibiotics
1 of 4
Experimental Treatment
46 Total Participants · 4 Treatment Groups
Primary Treatment: Whole Food Meal · No Placebo Group · N/A
Arm 2: Ultra-processed Meal + No Antibiotics
Other
Experimental Group · 1 Intervention: Ultra-processed Food Meal · Intervention Types: OtherArm 1: Ultra-processed Meal + Antibiotics to supress gut flora
Other
Experimental Group · 1 Intervention: Ultra-processed Food Meal · Intervention Types: OtherArm 3: Whole Food Meal + Antibiotics to supress gut flora
Other
Experimental Group · 1 Intervention: Whole Food Meal · Intervention Types: OtherArm 4: Whole Food Meal + No Antibiotics
Other
Experimental Group · 1 Intervention: Whole Food Meal · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
968 Previous Clinical Trials
1,361,211 Total Patients Enrolled
W. H. Wilson Tang, MDPrincipal InvestigatorThe Cleveland Clinic
7 Previous Clinical Trials
1,848 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Schugar, Rebecca C., Diana M. Shih, Manya Warrier, Robert N. Helsley, Amy Burrows, Daniel Ferguson, Amanda L. Brown, et al.. 2017. “The Tmao-producing Enzyme Flavin-containing Monooxygenase 3 Regulates Obesity and the Beiging of White Adipose Tissue”. Cell Reports. Elsevier BV. doi:10.1016/j.celrep.2017.05.077.
- Koh, Ara, Filipe De Vadder, Petia Kovatcheva-Datchary, and Fredrik Bäckhed. 2016. “From Dietary Fiber to Host Physiology: Short-chain Fatty Acids as Key Bacterial Metabolites”. Cell. Elsevier BV. doi:10.1016/j.cell.2016.05.041.
- Tang, W.H. Wilson, Zeneng Wang, Bruce S. Levison, Robert A. Koeth, Earl B. Britt, Xiaoming Fu, Yuping Wu, and Stanley L. Hazen. 2013. “Intestinal Microbial Metabolism of Phosphatidylcholine and Cardiovascular Risk”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1109400.
- Wang, Zeneng, Elizabeth Klipfell, Brian J. Bennett, Robert Koeth, Bruce S. Levison, Brandon DuGar, Ariel E. Feldstein, et al.. 2011. “Gut Flora Metabolism of Phosphatidylcholine Promotes Cardiovascular Disease”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature09922.
- Hall, Kevin D., Alexis Ayuketah, Robert Brychta, Hongyi Cai, Thomas Cassimatis, Kong Y. Chen, Stephanie T. Chung, et al.. 2019. “Ultra-processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake”. Cell Metabolism. Elsevier BV. doi:10.1016/j.cmet.2019.05.008.
- Srour, Bernard, Léopold K Fezeu, Emmanuelle Kesse-Guyot, Benjamin Allès, Caroline Méjean, Roland M Andrianasolo, Eloi Chazelas, et al.. 2019. “Ultra-processed Food Intake and Risk of Cardiovascular Disease: Prospective Cohort Study (nutrinet-santé)”. Bmj. BMJ. doi:10.1136/bmj.l1451.
- Tang, Zheng-Zheng, Guanhua Chen, Qilin Hong, Shi Huang, Holly M. Smith, Rachana D. Shah, Matthew Scholz, and Jane F. Ferguson. 2019. “Multi-omic Analysis of the Microbiome and Metabolome in Healthy Subjects Reveals Microbiome-dependent Relationships Between Diet and Metabolites”. Frontiers in Genetics. Frontiers Media SA. doi:10.3389/fgene.2019.00454.
- Hall, Kevin D., Alexis Ayuketah, Robert Brychta, Hongyi Cai, Thomas Cassimatis, Kong Y. Chen, Stephanie T. Chung, et al.. 2019. “Ultra-processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake”. Cell Metabolism. Elsevier BV. doi:10.1016/j.cmet.2019.05.008.
- Hall 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. Erratum In: Cell Metab. 2019 Jul 2;30(1):226. Cell Metab. 2020 Oct 6;32(4):690.
- Koh 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.
- Srour 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.
- Schugar 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. Erratum In: Cell Rep. 2017 Jul 5;20(1):279.
- Wilson Tang 2020. "Analysis of MicroBial Metabolites After Eating Refined Food". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04308473.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer