Validating eNose Measurement of Daily Fiber Intake

NCT05634044 | Completed

• 1 other identifier: 22041203-IRB01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Accuracy of this device to detect increased intake of fiber

  Assessed by comparing percentage change in volatile organic compounds (measured in OHMS) against the daily fiber intake in grams

  3 weeks

Secondary Outcomes (3)

• 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

  3 weeks

• Impact of fiber bar in microbiota composition

  3 weeks

• Tolerability of prebiotic bar

  3 weeks

Study Arms (1)

eNose device use

EXPERIMENTAL

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.

Device: eNose Device

Interventions

eNose Device 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.

eNose device use

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age 21-65, with no chronic medical diseases (mild and controlled hypertension, and controlled hyperlipidemia are acceptable).
• Willingness to eat 2 prebiotic bar per day for two weeks and collect stool samples three times, provide blood samples twice and complete questionnaires.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 1, 2022
• Study Start: November 8, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

US (1)