Garden-fresh Foods and Gut Microbiomes

NCT06506786 | Recruiting

• 1 other identifier: 2023-67017-39054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers

  ANOVA statistical test of bacterial gene copies (a proxy for absolute abundance) used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal bacterial abundance.

  Baseline, 1 week, 3 weeks

• Difference in fecal microbial diversity, as characterized by shotgun metagenomics.

  ANOVA statistical test of Shannon index used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial diversity.

  Baseline, 1 week, 3 weeks

• Difference in fecal microbial composition, as characterized by shotgun metagenomics.

  PERMANOVA statistical test used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial composition.

  Baseline, 1 week, 3 weeks

• Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics.

  Negative binomial GLM statistical test used to identify microbial taxa associated with either Garden-Fresh Produce or Supermarket Produce intervention.

  Baseline, 1 week, 3 weeks

Study Arms (2)

Garden First

EXPERIMENTAL

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.

Other: Garden-fresh Produce; Other: Supermarket Produce

Supermarket First

EXPERIMENTAL

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.

Other: Garden-fresh Produce; Other: Supermarket Produce

Interventions

Garden-fresh Produce OTHER

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

Garden First; Supermarket First

Supermarket Produce OTHER

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

Garden First; Supermarket First

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

Institute for Health in the Built Environment, University of Oregon

Eugene, Oregon, 97403, United States

RECRUITING

Study Officials

• Gwynne Mhuireach, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwynne Mhuireach, PhD

CONTACT

541-346-4694; gwynhwyf@uoregon.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: July 17, 2024
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)