Diet and Microbiome Longitudinal Monitoring With Food Intervention

Not Applicable

Active, not recruiting

• Conditions: Microbiome, Human; Gastrointestinal Tract
• Interventions: Other: Food provided from a commercial meal service provider for a week

• Registration Number: NCT04758715
• Lead Sponsor: University of Nebraska Lincoln

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 available

Study Timeline

• Study Start: 2021-02-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2030-02-28
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Food provided	Food provided from a commercial meal service provider for a week	Food provided from a commercial meal service provider for a week

Primary Outcome Measures

Name	Time	Method
Microbiota variation	Up to 2 weeks	Ecological statistics will be used to analyze the longitudinal microbiome composition modification

Trial Locations

Locations (1)

University of Nebraska - Lincoln; 🇺🇸 Lincoln, Nebraska, United States