Diet and Microbiome Longitudinal Monitoring With Food Int... | NCT04758715

Studies
Diet and Microbiome Longitudinal Monitoring With Food Intervention

NCT04758715

Sponsor

University of Nebraska Lincoln

Status

Active, not recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Microbiome, Human
Gastrointestinal Tract

Interventions

Food provided from a commercial meal service provider for a week

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2021Actual

Primary Completion Date

Feb 28, 2030Estimated

Completion Date

Feb 28, 2030Estimated

First Submitted Date

Feb 8, 2021

First Submission Date that Met QC Criteria

Feb 15, 2021

First Posted Date

Feb 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Food provided	Other	Food provided from a commercial meal service provider for a week	Other: Food provided from a commercial meal service provider for a week

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Food provided from a commercial meal service provider for a week	Other	Meals from a commercial meal service provider provide for a week to participant	Food provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microbiota variation	Ecological statistics will be used to analyze the longitudinal microbiome composition modification	Up to 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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,
History of organ transplant,
Shellfish allergy,
Insect allergy,
Cacti allergy,
Carmine allergy,
Dragon fruit (pitaya) allergy,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Izard, PhD	Univeristy of Nebraska-Lincoln	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska - Lincoln		Lincoln	Nebraska	68588	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided