Clinical trial NCT06506786: Garden-fresh Foods and Gut Microbiomes
Official title: Microbiomes of Garden-fresh vs Store-bought Produce and Variation in Their Effects on the Human Gut Microbiome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gut Microbiome
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers
timeFrame: Baseline, 1 week, 3 weeks
measure: Difference in fecal microbial diversity, as characterized by shotgun metagenomics.
timeFrame: Baseline, 1 week, 3 weeks
measure: Difference in fecal microbial composition, as characterized by shotgun metagenomics.
timeFrame: Baseline, 1 week, 3 weeks
measure: Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics.
timeFrame: Baseline, 1 week, 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Institute for Health in the Built Environment, University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Gwynne Mhuireach, PhD
role: PRINCIPAL_INVESTIGATOR
References: