Microbiome, HumanNCT04758715
Diet and Microbiome Longitudinal Monitoring With Food Intervention
A study testing Food provided from a commercial meal service provider for a week in people with Microbiome, Human and Gastrointestinal Tract, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiome, Human, Gastrointestinal Tract
- What is being tested?
- Food provided from a commercial meal service provider for a week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 28 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willing to sign consent and have samples collected,
- able to read and speak English,
- participants must be willing to use an electronic food diary and consume study provided foods,
- only individuals able to provide a US address will be included.
Who cannot join
- Subjects not able to sign consent on their own accord (ie requiring a Legally Authorized Representative [LAR]),
- Current parenteral nutrition,
- Received cancer treatment within past 6 months prior to signing consent,
- Taken antibiotic treatment within the past 1 month prior to signing consent,
- Received oral x-ray contrast within the past 1 month prior to signing consent,
- Received any type of gastrointestinal bowel preparation in the past 1 month prior to signing consent,
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- History of organ transplant,
- Shellfish allergy,
- Insect allergy,
- Cacti allergy,
- Carmine allergy,
- Dragon fruit (pitaya) allergy,
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska - Lincoln
Lincoln, Nebraska, 68588
About this study
The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.
- Conditions
- Microbiome, Human, Gastrointestinal Tract
- Being tested
- Food provided from a commercial meal service provider for a week
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food provided from a commercial meal service provider for a weekOther
Meals from a commercial meal service provider provide for a week to participant
| Study group | Role | What they receive |
|---|---|---|
| Food provided | Other | Food provided from a commercial meal service provider for a week Receives: Other: Food provided from a commercial meal service provider for a week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota variation
Ecological statistics will be used to analyze the longitudinal microbiome composition modification
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start2 Feb 2021
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiome, HumanStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Izard, PhD, Principal investigator, Univeristy of Nebraska-Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758715
- Sponsor's protocol ID
- 20117
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2021
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Microbiome Longitudinal Monitoring With Food Intervention
- ClinicalTrials.gov ID
- NCT04758715
- Acronym / sponsor ID
- 20117
- Conditions
- Microbiome, Human, Gastrointestinal Tract
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 17 Feb 2021 (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 main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food provided | Other | Other: Food provided from a commercial meal service provider for a weekFood provided from a commercial meal service provider for a week |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- willing to sign consent and have samples collected,
- able to read and speak English,
- participants must be willing to use an electronic food diary and consume study provided foods,
- only individuals able to provide a US address will be included.
Key exclusion criteria (12 listed)
- Subjects not able to sign consent on their own accord (ie requiring a Legally Authorized Representative [LAR]),
- Current parenteral nutrition,
- Received cancer treatment within past 6 months prior to signing consent,
- Taken antibiotic treatment within the past 1 month prior to signing consent,
- Received oral x-ray contrast within the past 1 month prior to signing consent,
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 |
|---|---|---|
| Food provided from a commercial meal service provider for a weekMeals from a commercial meal service provider provide for a week to participant | Other | Food provided |
Primary outcome
Microbiota variation
Time frame: Up to 2 weeks
Ecological statistics will be used to analyze the longitudinal microbiome composition modification
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- 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.
Jacques Izard, PhD principal investigator
Univeristy of Nebraska-Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food provided from a commercial meal service provider for a week in people with Microbiome, Human and Gastrointestinal Tract, run by University of Nebraska Lincoln 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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota variation (time frame: Up to 2 weeks). 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 7 May 2026.