Whole Food Meal for Eating Habits

Cleveland Clinic Main Campus, Cleveland, OH
Eating HabitsWhole Food Meal - Other
Eligibility
18+
All Sexes
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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

1 of 3
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

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: Other
Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora
Other
Experimental Group · 1 Intervention: Ultra-processed Food Meal · Intervention Types: Other
Arm 3: Whole Food Meal + Antibiotics to supress gut flora
Other
Experimental Group · 1 Intervention: Whole Food Meal · Intervention Types: Other
Arm 4: Whole Food Meal + No Antibiotics
Other
Experimental Group · 1 Intervention: Whole Food Meal · Intervention Types: Other

Trial 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

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References

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
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.