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OpenTrials
Active, Not Recruiting

NCT Number: NCT04758715

Diet and Microbiome Longitudinal Monitoring With Food Intervention

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Microbiome, Human Gastrointestinal Tract

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska - Lincoln

Lincoln, Nebraska, 68588, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

Primary outcomes

  1. Microbiota variation

    Time frame: Up to 2 weeks

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

Sponsors and collaborators

Lead sponsor

University of Nebraska Lincoln

Other

Registry information

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Feb 17, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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