NCT05634044

Validating eNose Measurement of Daily Fiber Intake

eNose Validation Study: Correlating Volatile Organic Compounds With Daily Fiber Intake

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-11-08
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2022-12-01
• Last updated: 2024-05-29

Locations

1 site across 1 country: United States