Garden-fresh Foods and Gut Microbiomes Study

This study is looking at how eating fruits and vegetables from your garden compared to those from a supermarket affects the tiny living organisms (microbes) in your gut. Researchers want to see if there are differences in the types and amounts of these microbes. You might be able to join if you are between 18 and 45 years old, have a healthy body mass index (BMI), and do not have irregular bowel movements. The study aims to understand these differences by measuring the bacteria in your stool at the beginning, after one week, and after three weeks. The current recruitment status is unclear.

Study design: This is an interventional study with 20 planned participants. It compares two groups: one eating garden-fresh produce and another eating supermarket produce.
What's involved: Participants are asked to eat USDA-recommended amounts of fruits and vegetables. Stool samples will be collected at the start, after one week, and after three weeks.
Compensation: Not stated in the trial record.
Follow-up: Your gut microbes will be measured at baseline, 1 week, and 3 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Garden-fresh Foods and Gut Microbiomes

UNKNOWN

NAAges 18–45InterventionalBasic science

University of Oregon

~20 participants

Updated 2024-07-17 on ClinicalTrials.gov

What's tested:Garden-fresh ProduceSupermarket Produce

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers

Measured over Baseline, 1 week, 3 weeks

+3 more outcomes measured

Conditions

Gut Microbiome

Where it's being run

1 sites across 1 states

Oregon1

Study leadership

Gwynne Mhuireach, PhD · PRINCIPAL_INVESTIGATOR · University of Oregon

Who to contact

Gwynne Mhuireach, PhD

[email protected]

541-346-4694

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primersBaseline, 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.

Trialytics