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Functional Research of Emulsifiers in Humans

NCT03440229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-10-19

Study results available
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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.

Conditions

  • Healthy

Interventions

OTHER

Emulsifier-containing diet

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.

Sponsors & Collaborators

  • Georgia State University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Jim Lewis, MD, MSCE · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2019-05-13
Completion
2019-05-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440229 on ClinicalTrials.gov