Recruiting

Gut Microbiomes

Sponsor:

University of Oregon

Code:

NCT06506786

Conditions

Gut Microbiome

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Garden-fresh Produce

Supermarket Produce

Study Details

Brief summary:

The purpose of this research is to explore what types of microbes are present on garden-fresh versus store-bought fruits and vegetables, as well as how they might affect the human gut microbiome.

Conditions

Gut Microbiome

Study ID

NCT06506786

Start date

Jul 1, 2023

Status verified date

Jul, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

-

Exclusion Criteria:

  • Body mass index (BMI) greater than or equal to 35 or less than or equal to 18.
  • Age under 18 or over 45.
  • Female who is pregnant or lactating.
  • Irregular bowel movements and/or stool consistency.
  • Plans to travel, move residences, or other major life change during the study period (August-October 2023).
  • Unable to speak, read, and write English.
  • Use of any of the following drugs within the last 6 months:
  • systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
  • oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
  • cytokines;
  • methotrexate or immunosuppressive cytotoxic agents;
  • large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
  • Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
  • History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
  • Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
  • Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.
  • Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.
  • Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
  • History of active uncontrolled gastrointestinal disorders or diseases including:
  • inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
  • irritable bowel syndrome (IBS) (moderate-severe);
  • persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
  • chronic constipation.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Garden First

Participants assigned to this study arm undergo the Garden-fresh Produce intervention during the first period and the Supermarket Produce intervention during the second period.

experimental: Supermarket First

Participants assigned to this study arm undergo the Supermarket Produce intervention during the first period and the Garden-fresh Produce intervention during the second period.

Interventions

Garden-fresh Produce

Participants are asked to consume the USDA-recommended amounts of fruits and vegetables harvested from their gardens.

Supermarket Produce

Participants are asked to consume the USDA-recommended amounts of fruits and vegetables purchased from a supermarket.

Primary outcome measure

  • Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers [ Time Frame: Baseline, 1 week, 3 weeks ]
  • Difference in fecal microbial diversity, as characterized by shotgun metagenomics. [ Time Frame: Baseline, 1 week, 3 weeks ]
  • Difference in fecal microbial composition, as characterized by shotgun metagenomics. [ Time Frame: Baseline, 1 week, 3 weeks ]
  • Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics. [ Time Frame: Baseline, 1 week, 3 weeks ]

Central Contacts and Locations

Central contacts

Gwynne Mhuireach, PhD

541-346-4694gwynhwyf@uoregon.edu

Locations

Institute for Health in the Built Environment, University of Oregon

Recruiting

Eugene, Oregon, United States, 97403

Contacts

Gwynne Mhuireach, PhD

541-346-4694gwynhwyf@uoregon.edu

Principal Investigator:

Gwynne Mhuireach, PhD

More Information

Sponsor

University of Oregon

Last update posted

Jul 17, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oregon on 2024-07-17.