Diet and Microbiome Longitudinal Monitoring With Food Intervention

NCT ID: NCT04758715

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2030-02-28

Brief Summary

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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

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Conditions

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Microbiome, Human Gastrointestinal Tract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Food provided

Food provided from a commercial meal service provider for a week

Group Type OTHER

Food provided from a commercial meal service provider for a week

Intervention Type OTHER

Meals from a commercial meal service provider provide for a week to participant

Interventions

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Food provided from a commercial meal service provider for a week

Meals from a commercial meal service provider provide for a week to participant

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nebraska Lincoln

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Izard, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Nebraska-Lincoln

Locations

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University of Nebraska - Lincoln

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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20117

Identifier Type: -

Identifier Source: org_study_id

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