Garden-fresh Foods and Gut Microbiomes

NCT ID: NCT06506786

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Garden-fresh Produce

Intervention Type: OTHER

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

Supermarket Produce

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Garden-fresh Produce

Intervention Type: OTHER

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

Supermarket Produce

Intervention Type: OTHER

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

Interventions

Garden-fresh Produce

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

Intervention Type: OTHER

Supermarket Produce

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gwynne Mhuireach, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

Institute for Health in the Built Environment, University of Oregon

Eugene, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gwynne Mhuireach, PhD

Role: CONTACT

gwynhwyf@uoregon.edu

541-346-4694

Facility Contacts

Gwynne Mhuireach, PhD

Role: primary

gwynhwyf@uoregon.edu

541-346-4694

Other Identifiers

2023-67017-39054

Identifier Type: -

Identifier Source: org_study_id