Terpene SynthasesNCStateNCT07589166
Identifying Terpenoid- and Carotenoid-modifying Enzymes in the Human Gut
An observational study of Terpene Synthases and Carotenoid Modifying Enzymes, run by North Carolina State University at 1 site in United States.
Trial summary
In this study, the investigators will collect fecal samples from healthy adults. The investigators will extract DNA from these fecal samples and use microbiological techniques to determine whether this DNA encodes enzymes that can react with certain chemicals called terpenoids and carotenoids. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Terpene Synthases, Carotenoid Modifying Enzymes
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Body Mass index <25
Who cannot join
- Pregnant
- Taken antibiotics or antifungals in the past 3 months
- Taken probiotic supplements in the past 3 months
- Diarrhea in the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phage-Enabled Mining of Gut Metagenomes for Terpenoid and Carotenoid Metabolism
In this study, the investigators will collect fecal samples from healthy adults. The investigators will extract DNA from these fecal samples and use microbiological techniques to determine whether this DNA encodes enzymes that can react with certain chemicals called terpenoids and carotenoids. The investigators will additionally collect dietary information via a questionnaire.
- Conditions
- Terpene Synthases, Carotenoid Modifying Enzymes
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unique gut metagenomic enzymes with carotenoid-modifying activities for each participant.
Subjects' fecal metagenomic DNA will be extracted from their fecal sample, and random fragments of this metagenomic DNA will be inserted into an E. coli expression vector. This vector library will be transformed into an E. coli strain that will change color if a carotenoid-modifying gene is present. We expect to obtain about one million E. coli clones per participant. These clones will be spread on agar plates, and the colonies exhibiting different colors will be recovered and sequenced. The sequences of each participant will be collected and annotated to determine putative carotenoid-modifying enzymes, and the number of unique enzymes will be saved.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start9 Sep 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terpene SynthasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Nathan Crook, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589166
- Sponsor's protocol ID
- 27363
- Other IDs
- R21AT012805
- Acronym
- NCState
- Status last verified
- May 2026
- First submitted
- 10 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fecal samples and data derived from them, including metagenome, metatranscriptome, metaproteome, and metabolome data will be provided to other researchers provided that they agree not to re-identify participants.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phage-Enabled Mining of Gut Metagenomes for Terpenoid and Carotenoid Metabolism
- ClinicalTrials.gov ID
- NCT07589166
- Acronym / sponsor ID
- NCState / 27363
- Conditions
- Terpene Synthases, Carotenoid Modifying Enzymes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 15 May 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.
In this study, the investigators will collect fecal samples from healthy adults. The investigators will extract DNA from these fecal samples and use microbiological techniques to determine whether this DNA encodes enzymes that can react with certain chemicals called terpenoids and carotenoids. The investigators will additionally collect dietary information via a questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (1 listed)
- Body Mass index <25
Key exclusion criteria (4 listed)
- Pregnant
- Taken antibiotics or antifungals in the past 3 months
- Taken probiotic supplements in the past 3 months
- Diarrhea in the past month
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | Healthy adults |
Primary outcome
Number of unique gut metagenomic enzymes with carotenoid-modifying activities for each participant.
Time frame: Day 1
Subjects' fecal metagenomic DNA will be extracted from their fecal sample, and random fragments of this metagenomic DNA will be inserted into an E. coli expression vector. This vector library will be transformed into an E. coli strain that will change color if a carotenoid-modifying gene is present. We expect to obtain about one million E. coli clones per participant. These clones will be spread on agar plates, and the colonies exhibiting different colors will be recovered and sequenced. The sequences of each participant will be collected and annotated to determine putative carotenoid-modifying enzymes, and the number of unique enzymes will be saved.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. Fecal samples and data derived from them, including metagenome, metatranscriptome, metaproteome, and metabolome data will be provided to other researchers provided that they agree not to re-identify participants.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Terpene Synthases and Carotenoid Modifying Enzymes, run by North Carolina State University 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 4 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: finished, as of the sponsor's last update on 20 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of unique gut metagenomic enzymes with carotenoid-modifying activities for each participant. (time frame: Day 1). 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 20 May 2026.