Diet and Microbiome Longitudinal Monitoring With Food Intervention

• Sponsor: University of Nebraska Lincoln (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04758715
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 108.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbiome, Human; Gastrointestinal Tract	Other: Food provided from a commercial meal service provider for a week	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Diet and Microbiome Longitudinal Monitoring With Food Intervention
• Actual Study Start Date: Feb 2, 2021
• Anticipated Primary Completion Date: Feb 28, 2030
• Anticipated Study Completion Date: Feb 28, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Microbiota variation [Up to 2 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska - Lincoln	Lincoln	Nebraska	United States	68588

Sponsors and Collaborators

• University of Nebraska Lincoln

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Nebraska Lincoln
• ClinicalTrials.gov Identifier: NCT04758715
• Other Study ID Numbers: 20117
• First Posted: Feb 17, 2021
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 18, 2022