Healthy EatingNCT07375329
Breath Hydrogen and Methane as Biomarkers of Fiber Intake
A study testing Breath Tester in people with Healthy Eating, run by University of Oklahoma at 1 site in United States.
Trial summary
This study is designed to examine if mobile phone-based breath hydrogen and methane monitors can be used as a biomarker of dietary fiber intake. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Healthy Eating
- What is being tested?
- Breath Tester
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be enrolled in parent trial (NCT07219706)
Who cannot join
- Not enrolled in parent trial (NCT07219706)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
About this study
Official title: Exploring the Utility of Breath Hydrogen and Methane as Biomarkers of Total Dietary Fiber Intake: A Pilot Study
This study is designed to examine if mobile phone-based breath hydrogen and methane monitors can be used as a biomarker of dietary fiber intake.
- Conditions
- Healthy Eating
- Being tested
- Breath Tester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath TesterOther
Participants enrolled in a fiber-focused study will be offered a Food Marble to see if the data provided correlates with self-reported fiber intake
| Study group | Role | What they receive |
|---|---|---|
| Breath Tester | Other | All participants will receive a breath tester Receives: Other: Breath Tester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath methane
Measured daily for three months, represented in parts per million (ppm)
Measured: Measured daily for three months
Breath hydrogen
Measured daily for three months, represented in parts per million (ppm)
Measured: Daily for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start28 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy EatingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashlea Braun, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375329
- Sponsor's protocol ID
- 18961
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Utility of Breath Hydrogen and Methane as Biomarkers of Total Dietary Fiber Intake: A Pilot Study
- ClinicalTrials.gov ID
- NCT07375329
- Acronym / sponsor ID
- 18961
- Conditions
- Healthy Eating
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine if mobile phone-based breath hydrogen and methane monitors can be used as a biomarker of dietary fiber intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath Tester | Other | Other: Breath TesterAll participants will receive a breath tester |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be enrolled in parent trial (NCT07219706)
Key exclusion criteria (1 listed)
- Not enrolled in parent trial (NCT07219706)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath TesterParticipants enrolled in a fiber-focused study will be offered a Food Marble to see if the data provided correlates with self-reported fiber intake | Other | Breath Tester |
Primary outcome
Breath methane
Time frame: Measured daily for three months
Measured daily for three months, represented in parts per million (ppm)
Breath hydrogen
Time frame: Daily for three months
Measured daily for three months, represented in parts per million (ppm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashlea Braun, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Tester in people with Healthy Eating, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath methane (time frame: Measured daily for three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.