Gut MicrobiomeGFFNCT06506786
Garden-fresh Foods and Gut Microbiomes
A study testing Garden-fresh Produce and Supermarket Produce in people with Gut Microbiome, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- Garden-fresh Produce and Supermarket Produce
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Institute for Health in the Built Environment, University of Oregon
Eugene, Oregon, 97403
Gwynne Mhuireach, PhD, 541-346-4694, gwynhwyf@uoregon.edu
Gwynne Mhuireach, PhD
About this study
Official title: Microbiomes of Garden-fresh vs Store-bought Produce and Variation in Their Effects on the Human Gut Microbiome
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
- Gut Microbiome
- Being tested
- Garden-fresh Produce, Supermarket Produce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garden-fresh ProduceOther
Participants are asked to consume the USDA-recommended amounts of fruits and vegetables harvested from their gardens.
Supermarket ProduceOther
Participants are asked to consume the USDA-recommended amounts of fruits and vegetables purchased from a supermarket.
| Study group | Role | What they receive |
|---|---|---|
| Garden First | Experimental | 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. Receives: Other: Garden-fresh Produce; Other: Supermarket Produce |
| Supermarket First | Experimental | 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. Receives: Other: Garden-fresh Produce; Other: Supermarket Produce |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers
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.
Measured: Baseline, 1 week, 3 weeks
Difference in fecal microbial diversity, as characterized by shotgun metagenomics.
ANOVA statistical test of Shannon index used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial diversity.
Measured: Baseline, 1 week, 3 weeks
Difference in fecal microbial composition, as characterized by shotgun metagenomics.
PERMANOVA statistical test used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial composition.
Measured: Baseline, 1 week, 3 weeks
Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics.
Negative binomial GLM statistical test used to identify microbial taxa associated with either Garden-Fresh Produce or Supermarket Produce intervention.
Measured: Baseline, 1 week, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwynne Mhuireach, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506786
- Sponsor's protocol ID
- 2023-67017-39054
- Other IDs
- 2023
- Acronym
- GFF
- Status last verified
- Jul 2024
- First submitted
- 24 May 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiomes of Garden-fresh vs Store-bought Produce and Variation in Their Effects on the Human Gut Microbiome
- ClinicalTrials.gov ID
- NCT06506786
- Acronym / sponsor ID
- GFF / 2023-67017-39054
- Conditions
- Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garden First | Experimental | Other: Garden-fresh Produce, Other: Supermarket ProduceParticipants assigned to this study arm undergo the Garden-fresh Produce intervention during the first period and the Supermarket Produce intervention during the second period. |
| Supermarket First | Experimental | Other: Garden-fresh Produce, Other: Supermarket ProduceParticipants assigned to this study arm undergo the Supermarket Produce intervention during the first period and the Garden-fresh Produce intervention during the second period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garden-fresh ProduceParticipants are asked to consume the USDA-recommended amounts of fruits and vegetables harvested from their gardens. | Other | Garden First, Supermarket First |
| Supermarket ProduceParticipants are asked to consume the USDA-recommended amounts of fruits and vegetables purchased from a supermarket. | Other | Garden First, Supermarket First |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwynne Mhuireach, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garden-fresh Produce and Supermarket Produce in people with Gut Microbiome, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwynne Mhuireach, PhD (541-346-4694, gwynhwyf@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers (time frame: Baseline, 1 week, 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.