Skip to main content
OpenTrials
Completed

NCT Number: NCT05634044

Validating eNose Measurement of Daily Fiber Intake

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dietary Fiber

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

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.

Primary outcomes

  1. Accuracy of this device to detect increased intake of fiber

    Time frame: 3 weeks

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

Secondary outcomes

  1. 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

    Time frame: 3 weeks

    Assessed by comparing eNose signal recordings (measured in OHMS) and each of three SCFA and total SCFA levels in stool

  2. Impact of fiber bar in microbiota composition

    Time frame: 3 weeks

    Assessed by 16s amplicon and function- SCFA levels

  3. Tolerability of prebiotic bar

    Time frame: 3 weeks

    Assessed by GI PROMIS questionnaires

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.