CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Emulsifier-containing dietother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03440229
NCT03440229N/ACompleted

Functional Research of Emulsifiers in Humans

University of Pennsylvania·interventional·Posted Feb 22, 2018·Updated Oct 19, 2021

In Brief

A clinical study evaluating Emulsifier-containing diet for Healthy. Completed, enrolled 29 participants across 1 site.

Detailed Summary

A randomized double-blind study of the effect of carboxymethylcellulose (CMC) on stool microbiota composition, microbiota localization, and metabolic parameters in healthy subjects. It includes a 11-day in-patient stay, randomization to an emulsifier-free group or a CMC group with the same diet except baked goods/sorbet with added CMC at 15g/person/day.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartApr 6, 2018
Primary CompletionMay 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.4 years ago

Interventions

Emulsifier-containing dietother

CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota.