Validating eNose Measurement of Daily Fiber Intake

Sponsor

Rush University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05634044

Collaborator

(none)

Enrollment

Location

Arm

11.8

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 2-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 2-week period.

Condition or Disease	Intervention/Treatment	Phase
Dietary Fiber	Device: eNose Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Nov 8, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eNose device use 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 3 visits during a 2 week period.	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 3 visits during a 2-week period.

Arm

Intervention/Treatment

Experimental: eNose device use

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 3 visits during a 2 week period.

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 3 visits during a 2-week period.

Outcome Measures

Primary Outcome Measures

Accuracy of this device to detect increased intake of fiber [2 weeks]
Assessed by comparing percentage change in volatile organic compounds (measured in OHMS) against the daily fiber intake in grams

Secondary Outcome Measures

Ability of eNose to detect increased production of SCFA- positive correlation between enose signals and each of three SCFA and total SCFA levels in stool [2 weeks]
Assessed by comparing eNose signal recordings (measured in OHMS) and each of three SCFA and total SCFA levels in stool
Impact of fiber bar in microbiota composition [2 weeks]
Assessed by 16s amplicon and function- SCFA levels
Tolerability of prebiotic bar [2 weeks]
Assessed by GI PROMIS questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and females, age 30-65, with no chronic medical diseases (mild and controlled hypertension, and controlled hyperlipidemia are acceptable).
Willingness to eat 1 prebiotic bar per day for one week and collect stool samples three times, provide blood samples twice and complete questionnaires 3 times during each of the three study visits (visit 2 is virtual).

Exclusion Criteria:

Patients on a restricted diet (e.g., gluten-free diet, Paleo diet, vegetarian or vegan diet)
Allergy to almonds, flax seed, or coconuts
Chronic GI disorders (Inflammatory bowel disease, Irritable Bowel Syndrome on regular therapy taking fiber or MiraLAX is acceptable to be enrolled; celiac disease, colon cancer, intestinal resection,)
Chronic NSAID use (more than 3 days per week)
Antibiotic use in the last 12 weeks
BMI > 35 or < 18
Inability to sign an informed consent form
Non-English speaker

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robin Voigt, Principle Investigator, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT05634044

Other Study ID Numbers:

22041203-IRB01

First Posted:

Dec 1, 2022

Last Update Posted:

Dec 1, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 1, 2022