Identifying Terpenoid- and Carotenoid-modifying Enzymes in the Human Gut

NCT07589166 | Completed DMC

• 2 other identifiers: 27363R21AT012805
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. The investigators will additionally collect dietary information via a questionnaire.

Conditions

Terpene Synthases; Carotenoid Modifying Enzymes

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Study Arms (1)

Healthy adults

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention

Healthy adults

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

You may qualify if:

• Body Mass index \<25

You may not qualify if:

• Pregnant
• Taken antibiotics or antifungals in the past 3 months
• Taken probiotic supplements in the past 3 months
• Diarrhea in the past month

Sponsors & Collaborators

• North Carolina State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

NC State University

Raleigh, North Carolina, 27606, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Feces

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 15, 2026
• Study Start: September 9, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)