Garden-fresh Foods and Gut Microbiomes (GFF)

University of Oregon

Status: Enrolling

Conditions: Gut Microbiome

Treatments: Other: Supermarket Produce; Other: Garden-fresh Produce

Study type: Interventional

Funder types: Other

Identifiers

NCT06506786

2023-67017-39054

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Garden First

Experimental group

Description:

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.

Treatment:

Other: Garden-fresh Produce

Other: Supermarket Produce

Supermarket First

Experimental group

Description:

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.

Treatment:

Other: Garden-fresh Produce

Other: Supermarket Produce