Exploring the impact of garden-fresh versus store-bought produce on gut microbes

Microbiomes of Garden-fresh vs Store-bought Produce and Variation in Their Effects on the Human Gut Microbiome

This study tests whether eating garden-fresh fruits and vegetables affects gut health differently than eating store-bought produce.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Oregon (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Eugene, Oregon)
• Trial ID: NCT06506786 on ClinicalTrials.gov

What this trial studies

This research investigates the types of microbes found on garden-fresh fruits and vegetables compared to those from supermarkets, and how these microbes may influence the human gut microbiome. Participants will consume either garden-fresh or supermarket produce, and their gut microbiomes will be analyzed to assess any differences. The study aims to provide insights into how the source of produce affects gut health and microbial diversity.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 45 with a normal body mass index and no recent use of specific medications that could affect gut microbiota.

Not a fit: Patients with a BMI outside the normal range, those under 18 or over 45, and individuals with irregular bowel movements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of how different food sources impact gut health, potentially leading to dietary recommendations for improved microbiome health.

How similar studies have performed: While there is ongoing research into the effects of diet on the gut microbiome, this specific comparison of garden-fresh versus store-bought produce is relatively novel.

Eligibility criteria

Inclusion Criteria:

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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.

Where this trial is running

Eugene, Oregon

• Institute for Health in the Built Environment, University of Oregon — Eugene, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Gwynne Mhuireach, PhD — University of Oregon
• Study coordinator: Gwynne Mhuireach, PhD

Conditions: Gut Microbiome