NCT06506786 · University of Oregon
Garden-fresh Foods and Gut Microbiomes
(GFF)
What this study is 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.
View original scientific description
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
OTHER
Garden-fresh Produce
Participants are asked to consume the USDA-recommended amounts of fruits and vegetables harvested from their gardens.
OTHER
Supermarket Produce
Participants are asked to consume the USDA-recommended amounts of fruits and vegetables purchased from a supermarket.
Primary outcome measures
Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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;
- 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
- Eugene, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2024 · Source of record for eligibility and locations