Gut Microbiome
Conditions
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.
Interventions
OTHERGarden-fresh Produce
Participants are asked to consume the USDA-recommended amounts of fruits and vegetables harvested from their gardens.
OTHERSupermarket Produce
Participants are asked to consume the USDA-recommended amounts of fruits and vegetables purchased from a supermarket.
Sponsors
University of Oregon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in fecal bacterial abundance, as characterized by qPCR with universal bacterial primers | Baseline, 1 week, 3 weeks | 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. |
| Difference in fecal microbial diversity, as characterized by shotgun metagenomics. | Baseline, 1 week, 3 weeks | ANOVA statistical test of Shannon index used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial diversity. |
| Difference in fecal microbial composition, as characterized by shotgun metagenomics. | Baseline, 1 week, 3 weeks | PERMANOVA statistical test used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial composition. |
| Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics. | Baseline, 1 week, 3 weeks | Negative binomial GLM statistical test used to identify microbial taxa associated with either Garden-Fresh Produce or Supermarket Produce intervention. |
Countries
United States
Contacts
Primary ContactGwynne Mhuireach, PhD
Outcome results
None listed