Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT06506786

Garden-fresh Foods and Gut Microbiomes

Led by University of Oregon · Updated on 2024-07-17

20

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Garden-fresh Foods and Gut Microbiomes

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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Not Eligible

You will not qualify if you...

  • 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 10^8 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute for Health in the Built Environment, University of Oregon

Eugene, Oregon, United States, 97403

Actively Recruiting

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Research Team

G

Gwynne Mhuireach, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Garden-fresh Foods and Gut Microbiomes | DecenTrialz