Diet and Microbiome Longitudinal Monitoring With Food Intervention

University of Nebraska

Status: Active, not recruiting

Conditions: Gastrointestinal Tract; Microbiome, Human

Treatments: Other: Food provided from a commercial meal service provider for a week

Study type: Interventional

Funder types: Other

Identifiers

NCT04758715

20117

Details and patient eligibility

About

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

Enrollment: 65 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Food provided

Other group

Description:

Food provided from a commercial meal service provider for a week

Treatment:

Other: Food provided from a commercial meal service provider for a week