Garden-fresh Foods and Gut Microbiomes
Purpose
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.
Condition
- Gut Microbiome
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Experimental 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. |
|
Recruiting Locations
Institute for Health in the Built Environment, University of Oregon
Eugene, Oregon 97403
Eugene, Oregon 97403
More Details
- Status
- Recruiting
- Sponsor
- University of Oregon