Diet and Microbiome Longitudinal Monitoring With Food Intervention

Gastrointestinal Tract Clinical Trial

Official title:

Diet and Microbiome Longitudinal Monitoring With Food Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04758715
• Other study ID #: 20117
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: February 28, 2030

Study information

• Verified date: August 2023
• Source: University of Nebraska Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: February 28, 2030
• Est. primary completion date: February 28, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Gastrointestinal Tract
• Microbiome, Human

Intervention

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

Locations

Country	Name	City	State
United States	University of Nebraska - Lincoln	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska Lincoln

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota variation	Ecological statistics will be used to analyze the longitudinal microbiome composition modification	Up to 2 weeks