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Validating eNose Measurement of Daily Fiber Intake

NCT05634044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-05-29

No results posted yet for this study

Summary

Monitoring dietary intake and digestion is important for both medical monitoring and assessing the wellness of individuals. Fiber is an important nutrient that is not focused on enough, despite it being an essential nutrient for the bacteria and other micro-organisms that reside in our GI Tracts, known as the microbiome. Ingestion of fermentable soluble and insoluble dietary fiber has been shown to result in the production of short-chain fatty acids (SCFA) by the colonic microbiome. These SCFAs are volatile organic compounds (VOCs) and can be detected in the atmosphere of a bowel movement. We have developed an e-Nose device that once placed in the bathroom records volatile organic compounds (VOCs) from the ambient air. We have demonstrated in an "N of 1" study a strong correlation between the eNose output and grams of daily fiber intake.

The current study is being proposed to validate the e-Nose device on a larger population. This is a nonmedical device that is not regulated by the FDA. A total of 40 subjects are invited to participate in this 3-week study. Participants will be asked to complete questionnaires and provide stool and blood samples. The subjects will place the eNose device in their bathroom and record their daily food intake over a 3-week period.

Conditions

  • Dietary Fiber

Interventions

DEVICE

eNose Device

Participants will place the e-Nose device in their bathroom to record VOCs from the ambient air after they have a bowel movement. In addition to this, all participants will complete 2 blood draws 3 stool collections and questionnaires over the course of 4 visits during a 3-week period.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2023-10-13
Completion
2023-10-13

Countries

  • United States

Study Locations

More Related Trials

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 NCT05634044 on ClinicalTrials.gov