Diet and Microbiome Longitudinal Monitoring With Food Intervention

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Tract; Microbiome, Human
• Intervention / Treatment: Other: Food provided from a commercial meal service provider for a week

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68588
      • University of Nebraska - Lincoln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Food provided; Food provided from a commercial meal service provider for a week	Other: Food provided from a commercial meal service provider for a week; Meals from a commercial meal service provider provide for a week to participant

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Nebraska Lincoln
• Investigators: Principal Investigator: Jacques Izard, PhD, Univeristy of Nebraska-Lincoln

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No