Diet and Microbiome Longitudinal Monitoring With Food Intervention

NCT04758715 | Active Not Recruiting

• 1 other identifier: 20117
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiome, Human; Gastrointestinal Tract

Outcome Measures

Primary Outcomes (1)

• Microbiota variation

  Ecological statistics will be used to analyze the longitudinal microbiome composition modification

  Up to 2 weeks

Study Arms (1)

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

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Sites (1)

University of Nebraska - Lincoln

Lincoln, Nebraska, 68588, United States

Location

Study Officials

• Jacques Izard, PhD

  Univeristy of Nebraska-Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 17, 2021
• Study Start: February 2, 2021
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)